Lower risk Medical device recall · FDA · Published October 13, 2020

Luminex Verigene Processor SP Model 10-0000-07R Recall: Unapproved Test Fixtures Risk

Luminex recalls Verigene Processor SP models 10-0000-07 and 10-0000-07R used with Gram-Positive Blood tests due to unapproved test fixtures causing calibration errors. Affected units have specific serial numbers listed in the recall.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0476-2021Medical device Luminex ›

Lower-risk recall

Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENESP devices.

Take action

Contact the company

Recalling firmLuminex Corporation4088 Commercial Ave · Northbrook, IL 60062-1829

✎ GovInfoNow plain-language explainer

Luminex is recalling Verigene Processor SP models 10-0000-07 and 10-0000-07R that were used with Gram-Positive Blood tests. The recall is because field service engineers used unapproved test fixtures to calibrate these devices, which could lead to inaccurate test results. Read more at govinfonow.com/recall/64095-luminex-verigene-processor-sp-model-10-0000-07r-recall-unapproved.

Source Summary by GovInfoNow · govinfonow.com/recall/64095-luminex-verigene-processor-sp-model-10-0000-07r-recall-unapproved · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0476-2021

Cite this page

“Luminex Verigene Processor SP Model 10-0000-07R Recall: Unapproved Test Fixtures Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64095-luminex-verigene-processor-sp-model-10-0000-07r-recall-unapproved. Based on FDA recall #Z-0476-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0476-2021%22&limit=1).

The Food and Drug Administration announced on Oct. 13, 2020, that Luminex Corporation is recalling Verigene Processor SP devices due to the use of unapproved test fixtures in their calibration. The agency said the fixtures were procured from unapproved sources and manufactured using unvalidated processes.

How to tell if you have it

Brand: Luminex
Product: Verigene Processor SP
Model Numbers: 10-0000-07, 10-0000-07R
Units affected: 2838

The hazard

Luminex determined that three separate test fixtures used by field service engineers to calibrate and verify the devices were procured from unapproved sources. In some cases, these fixtures were manufactured using unvalidated processes.

Context

GovInfoNow's records show Luminex Corporation has 22 other recalls on record since May 8, 2018. Other recent recalls of similar products include the Luminex VERIGENE Gram Negative Blood Culture Test Recall (April 16, 2025), the Luminex Verigene Gram Positive Blood Culture Test Recall (June 20, 2024), and the Luminex VERIGENE BC-GP Utility Tray Recall (Nov. 7, 2023). Other recent recalls of similar products include the Fujirebio Lumipulse G Amyloid 1-42 Plasma Calibrators Recall (Dec. 11, 2025), the Philips Brilliance CT 64 Medical Scanner Recall (Aug. 7, 2026), and the Fujirebio Lumipulse pTau 217 Plasma Controls Recall (Dec. 11, 2025).

How to tell if you have this one

Check if your Verigene Processor SP has model numbers 10-0000-07 or 10-0000-07R. The specific serial numbers listed in the recall document indicate affected units.

Brand
Luminex
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Worldwide distribution. US nationwide and Kuwait, Austria, United Kingdom, Spain, France, Chile, Japan, Netherlands, Greece, Italy, Thailand, Germany, Turkey

Recall number	Product, codes & lots
Z-0476-2021	Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.; UDI 00857573006010 Model Number 10-0000-07, Serial Numbers: 10110051, 10110050, 10110048, 10110047, 10099033, 10099032, 10099029, 10043027, 10043025, 10043024, 10043023, 10035106, 10035105, 10014003, 10014001, 9350165, 9350164, 9350163, 9350161, 9350160, 9350159, 9336156, 9336150, 9336149, 9336148, 9336147, 9336146, 9336145, 9336144, 9325152, 9325151, 9325138, 9320127, 9313124, 9313123, 9313122, 9313121, 9313120, 9313119, 9298118, 9298117, 9298116, 9293111, 9293109, 9293106, 9293103, 9288102, 9288097, 9288096, 9288095, 9277094, 9277093, 9277092, 9277091, 9277090, 9277089, 9277088, 9270087, 9270086, 9270085, 9270084, 9270082, 9270080, 9255080, 9255079, 9255077, 9255072, 9255071, 9230075, 9230074, 9230070, 9230069, 9230068, 9230067, 9230066, 9230065, 9230064, 9230063, 9210062, 9210061, 9210059, 9210058, 9210057, 9210056, 9202052, 9202047, 9163046, 9163045, 9163044, 9163044, 9163043, 9163042, 9163041, 9163040, 9163039, 9163038, 9163035, 9163034, 9135029, 9135028, 9135027, 9135026, 9121022, 9121021, 9121019, 9121018, 9121017, 9121015, 911, 9100014, 9100012, 9100011, 9100009, 9098006, 9098005, 9098003, 9098002, 9098001, 907, 902, 10035017R, 10014012 Correct, 10014012, D09336158, 9336158, D09336157, 9336157, D09135024, 9135024, D0912, 912, D0909, 909, D908, D0908, 908, 18255014, 18150007, 18120010, 18120003, 17333003, 17250008, 17250005, 17250002, 17130060, 17017006, 16334077, 13154206, 13154205, 13154204, 13154203, 13154202, 13008020, 12333423, 12324418, 12324417, 12324416, 12324415, 12324414, 12254308, 12254307, 12254306, 12254305, 12248296, 12333422, 12333420, 12333419, 20212005, 20007006, 20007005, 20007004, 20007002, 20007001, 19317003, 19317002, 19295003, 19095010, 19031003, 18333008, 18318006, 18264010, 18250012, 18250011, 18205003, 18191003, 18060006, 18060006, 17250007, 17234003, 17234002, 17234001, 17017001, 16277051, 15015004, 14211179, 14211178, 14211174, 13178239, 13178238, 13178237, 13178236, 13154201, 13140200, 13140199, 12086072, 12079070, 12079069, 12079065, 9298112, 9210055, 9202054, 12136125, 12128124, 12045028, 12045027, 12045026, 11250109, 11186056, 11186055, 11152050, 11152049, 11152048, 10102046, 18046009, 12061043, 12061042, 18026001, 17250010, 17250009, 19295006, 13105147, 13024036, 13024035, 13024033, 12219234, 12079068, 12079066, 11101027, 11276129, 17242010, 17242009, 17242008, 12107095, 12107094, 12107093, 12107092, 12107091, 18288014, 18288011, 17017003, 14090077, 13105148, 19095002, 13154208, 13154207, 13105146, 12285351, 12285350, 12219238, 12219233, 12053038, 12053036, 11339156, 11213084, 12240286, 12240285, 12240284, 12240283, 12240282, 12240281, 12240280, 12045030, 12045029, 10110062, 10110061, 10110060, 19192009, 19095005, 18054010, 18054009, 18054008, 17117050, 17117049, 17117048, 15327106, 15327105, 15327104, 15327103, 15327102, 15327101, 15320100, 15320099, 15320098, 15320097, 15320096, 15320095, 15320094, 15320093, 14251231, 14244229, 14244228, 13066086, 12205215, 11276128, 11276127, 9202053, 18255004, 18250010, 18172008, 13161218, 13105149, 13105145, 12219236, 12079064, 12079061, 11276121, 11276111, 11152052, 11152051, 10250123, 10250120, 10139083, 10139081, 10139080, 10099037, 14237220, 14237218, 14237216, 15040039, 15040038, 13099133, 13099132, 13099131, 12156156, 12156155, 17234007, 14090075, 14090074, 14090073, 13161219, 11276114, 11276113, 11276112, 10250121, 15327110, 14090076, 13042052, 13024038, 11250095, 11250094, 10182100, 13210280, 13210279, 18288012, 17017002, 13024037, 13024034, 12285353, 12285352, 12285349, 12223239, 12219237, 12219235, 12086071, 11186054, 11152053, 11152045, 10250122, 10139082 Model Number 10-0000-07R, Serial Numbers: 11186058, 9298111, 18255010, 17215009, 17096033, 16277053, 16125025, 15131079, 14191153, 13178234, 20094002, 19295001, 19260003, 19233003, 19206005, 19123005, 19123002, 19095013, 19095001, 19084015, 19084013, 19084012, 19084011, 19084001, 19072009, 19072006, 19057013, 19036003, 19036002, 18344008, 18344004, 18333001, 18318015, 18318009, 18299012, 18299008, 18299007, 18299003, 18288008, 18264008, 18264007, 18264006, 18264002, 18255015, 18255008, 18255006, 18250013, 18250008, 18235009, 18235007, 18235005, 18226013, 18226012, 18226011, 18226007, 18226001, 18214007, 18205006, 18191012, 18177012, 18172008, 18159015, 18159014, 18156011, 18150006, 18150004, 18150003, 18141007, 18128004, 18120008, 18099006, 18088005, 18088004, 18088003, 18072009, 18072005, 18072004, 18060010, 18060009, 18057009, 18046010, 18046005, 18046004, 18046003, 18046002, 18046001, 18039007, 18039005, 18039004, 18037005, 18037004, 18037003, 18037002, 18037001, 18026003, 18024002, 18023007, 18022003, 17347002, 17347001, 17340004, 17333001, 17307003, 17307001, 17296010, 17296009, 17296008, 17296007, 17296006, 17296005, 17284009, 17284006, 17284001, 17278001, 17262010, 17215008, 17215005, 17215001, 17177002, 17177001, 17130059, 17117044, 17096037, 17096035, 17096032, 17096031, 17062026, 16347084, 16299066, 16299062, 16299061, 16242043, 16242041, 16214036, 16077013, 16049002, 16049001, 15327109, 15208089, 15208088, 15208087, 15208081, 15131072, 15131071, 15096063, 15075060, 15075056, 15075053, 15075051, 15055046, 15055044, 15055042, 15040033, 15033025, 15033024, 15033022, 15033021, 15020018, 15020017, 15020016, 15020015, 15020014, 15020013, 15020012, 14322269, 14322267, 14322267, 14322262, 14322261, 14307260, 14307259, 14307258, 14307257, 14307256, 14265246, 14265245, 14265241, 14251240, 14251239, 14251238, 14251237, 14251234, 14251233, 14244230, 14244221, 14237215, 14230205, 14230204, 14230203, 14230202, 14224199, 14218181, 14211180, 14211177, 14211173, 14211172, 14191158, 14191157, 14191155, 14191154, 14182150, 14182149, 14182143, 14182142, 14177138, 14177137, 14177135, 14177134, 14155128, 14155124, 14155123, 14155122, 14155121, 14142116, 14142115, 14142114, 14142112, 14142111, 14139110, 14139109, 14139108, 14139107, 14139106, 14139104, 14139103, 14118093, 14118092, 14111087, 14111086, 14111084, 14111081, 14090079, 14083069, 14083068, 14083067, 14083066, 14083065, 14083064, 14083063, 14069060, 14069053, 14069052, 14069051, 14062050, 14062047, 14062042, 14062041, 14052036, 14052035, 14052034, 14052033, 14043030, 14043029, 14043028, 14043026, 14043024, 14043023, 14043022, 14006009, 14006001, 13315359, 13315358, 13315355, 13315354, 13315353, 13315351, 13301350, 13301347, 13301344, 13301341, 13274340, 13274337, 13274336, 13274335, 13274334, 13274332, 13245318, 13245315, 13245314, 13245313, 13245312, 13245311, 13238310, 13238309, 13238307, 13238306, 13238305, 13238304, 13238301, 13227296, 13224290, 13224288, 13224287, 13224285, 13224282, 13224281, 13210278, 13210277, 13210276, 13210275, 13210274, 13203270, 13203269, 13203265, 13203264, 13203263, 13203262, 13203261, 13193260, 13193258, 13193257, 13186249, 13186248, 13186247, 13186246, 13186245, 13186241, 13178240, 13178233, 13178232, 13178231, 13170229, 13170227, 13170226, 13170225, 13170224, 13161217, 13161216, 13161215, 13161214, 13161211, 13154210, 13154209, 13140197, 13140196, 13140195, 13140194, 13140193, 13140192, 13140191, 13133190, 13133189, 13133188, 13133187, 13133184, 13133182, 13127180, 13127174, 13127173, 13127172, 13127171, 13121166, 13121165, 13121164, 13121163, 13121162, 13121161, 13112160, 13112159, 13112152, 13112151, 13105150, 13099140, 13099139, 13099138, 13099137, 13092130, 13092129, 13092126, 13087116, 13087115, 13087114, 13087111, 13079110, 13079104, 13079103, 13079102, 13079101, 13072093, 13072092, 13072091, 13066089, 13066088, 13066085, 13066084, 13066081, 13060080, 13060074, 13051068, 13051067, 13051066, 13051064, 13051063, 13051062, 13042060, 13042059, 13037048, 13037041, 13024040, 13024039, 13018029, 13018028, 13018027, 13018024, 13008017, 13008014, 13008013, 13008011, 13003008, 13003003, 12340438, 12333428, 12333427, 12333426, 12324412, 12324411, 12317408, 12317407, 12317406, 12317404, 12317403, 12317400, 12310398, 12310396, 12310393, 12310392, 12310391, 12310390, 12310389, 12305384, 12305383, 12305381, 12303374, 12303373, 12303372, 12303371, 12303370, 12303369, 12292368, 12292363, 12292359, 12285358, 12285357, 12285356, 12278348, 12278347, 12278345, 12278344, 12278343, 12278342, 12278341, 12278339, 12271338, 12271337, 12271336, 12271335, 12271334, 12271333, 12271332, 12271331, 12271330, 12271329, 12268328, 12268327, 12268326, 12268323, 12261315, 12261313, 12254303, 12254302, 12254301, 12254300, 12254299, 12248298, 12248297, 12248295, 12248294, 12248293, 12248289, 12240288, 12240287, 12240279, 12236278, 12233265, 12233261, 12233260, 12229257, 12229256, 12229255, 12229254, 12229253, 12229250, 12229249, 12223248, 12223247, 12223246, 12223245, 12223244, 12223241, 12219230, 12219229, 12205214, 12205213, 12205212, 12205211, 12205210, 12205209, 12198208, 12198207, 12198206, 12198205, 12198204, 12198203, 12198202, 12198201, 12198200, 12198199, 12198198, 12198197, 12198196, 12175193, 12175192, 12175188, 12175187, 12175186, 12175185, 12175180, 12170178, 12170174, 12170167, 12156162, 12156161, 12145148, 12145147, 12145146, 12145145, 12142140, 12142139, 12142138, 12136135, 12136133, 12136132, 12136131, 12136129, 12128121, 12128120, 12128117, 12128116, 12128115, 12128114, 12128113, 12111107, 12111106, 12111105, 12111104, 12111103, 12111102, 12111101, 12107100, 12107096, 12088090, 12086077, 12086074, 12069058, 12069051, 12061049, 12061047, 12061044, 12053040, 12053035, 12053033, 12053032, 12053031, 12045025, 12045024, 12038020, 12038019, 12016010, 12016009, 12016008, 12016007, 12016006, 12016005, 11339155, 11339154, 11339150, 11306147, 11306146, 11306143, 11306140, 11306139, 11306138, 11306136, 11306134, 11276120, 11276119, 11276118, 11276117, 11276116, 11276115, 11276110, 11250104, 11250097, 11250092, 11250091, 11236088, 11236087, 11213086, 11213085, 11213083, 11213082, 11213077, 11213070, 11213069, 11213068, 11213067, 11186066, 11186065, 11186064, 11186060, 11186059, 11186057, 11122040, 11122039, 11122038, 11122037, 11122036, 11122035, 11101032, 11101031, 11101030, 11101029, 11101028, 11068022, 11068020, 11068019, 11068018, 11068017, 11040016, 11040015, 11040014, 11040012, 11040011, 11040010, 11040009, 11021008, 11021007, 11021006, 11021005, 11021004, 11021002, 11021001, 10350172, 10350171, 10350170, 10350169, 10350168, 10350167, 10350166, 10350165, 10336164, 10336163, 10336162, 10336161, 10336160, 10336159, 10336158, 10336157, 10336156, 10336155, 10295154, 10295153, 10295152, 10295151, 10295150, 10278134, 10278130, 10278129, 10278127, 10278126, 10278125, 10250124, 10250115, 10210114, 10210113, 10182099, 10182098, 10182097, 10162091, 10162090, 10162088, 10162086, 10139079, 10119077, 10119075, 10119072, 10110059, 10102045, 10099044, 10099043, 10099042, 10099041, 10099040, 10099039, 10099038, 10099036, 10099035, 10099031, 10099030, 10043026, 10043022, 10043021, 10035020, 10035019, 10035018, 10035014, 10035013, 10014011, 10014010, 10014009, 10014008, 10014007, 10014006, 10014005, 10014002, 9350166, 9336154, 9336153, 9336152, 9336151, 9336143, 9325142, 9325141, 9325140, 9325139, 9325137, 9313125, 9293110, 9293108, 9293107, 9293105, 9293104, 9288100, 9288099, 9288098, 9277087, 9270083, 9270081, 9270079, 9255076, 9202049, 9163036, 9163033, 9163032, 9135030, 9135023, 9121016, 9100013, 9100008, 10035017, D09288101, 15015004, 12079067, 11101026, 11101025, 11068024, 11068023, 10035016, 10035015
Z-0477-2021	Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.; UDI 00857573006010 Model Number 10-0000-07, Serial Numbers: 10110051, 10110050, 10110048, 10110047, 10099033, 10099032, 10099029, 10043027, 10043025, 10043024, 10043023, 10035106, 10035105, 10014003, 10014001, 9350165, 9350164, 9350163, 9350161, 9350160, 9350159, 9336156, 9336150, 9336149, 9336148, 9336147, 9336146, 9336145, 9336144, 9325152, 9325151, 9325138, 9320127, 9313124, 9313123, 9313122, 9313121, 9313120, 9313119, 9298118, 9298117, 9298116, 9293111, 9293109, 9293106, 9293103, 9288102, 9288097, 9288096, 9288095, 9277094, 9277093, 9277092, 9277091, 9277090, 9277089, 9277088, 9270087, 9270086, 9270085, 9270084, 9270082, 9270080, 9255080, 9255079, 9255077, 9255072, 9255071, 9230075, 9230074, 9230070, 9230069, 9230068, 9230067, 9230066, 9230065, 9230064, 9230063, 9210062, 9210061, 9210059, 9210058, 9210057, 9210056, 9202052, 9202047, 9163046, 9163045, 9163044, 9163044, 9163043, 9163042, 9163041, 9163040, 9163039, 9163038, 9163035, 9163034, 9135029, 9135028, 9135027, 9135026, 9121022, 9121021, 9121019, 9121018, 9121017, 9121015, 911, 9100014, 9100012, 9100011, 9100009, 9098006, 9098005, 9098003, 9098002, 9098001, 907, 902, 10035017R, 10014012 Correct, 10014012, D09336158, 9336158, D09336157, 9336157, D09135024, 9135024, D0912, 912, D0909, 909, D908, D0908, 908, 18255014, 18150007, 18120010, 18120003, 17333003, 17250008, 17250005, 17250002, 17130060, 17017006, 16334077, 13154206, 13154205, 13154204, 13154203, 13154202, 13008020, 12333423, 12324418, 12324417, 12324416, 12324415, 12324414, 12254308, 12254307, 12254306, 12254305, 12248296, 12333422, 12333420, 12333419, 20212005, 20007006, 20007005, 20007004, 20007002, 20007001, 19317003, 19317002, 19295003, 19095010, 19031003, 18333008, 18318006, 18264010, 18250012, 18250011, 18205003, 18191003, 18060006, 18060006, 17250007, 17234003, 17234002, 17234001, 17017001, 16277051, 15015004, 14211179, 14211178, 14211174, 13178239, 13178238, 13178237, 13178236, 13154201, 13140200, 13140199, 12086072, 12079070, 12079069, 12079065, 9298112, 9210055, 9202054, 12136125, 12128124, 12045028, 12045027, 12045026, 11250109, 11186056, 11186055, 11152050, 11152049, 11152048, 10102046, 18046009, 12061043, 12061042, 18026001, 17250010, 17250009, 19295006, 13105147, 13024036, 13024035, 13024033, 12219234, 12079068, 12079066, 11101027, 11276129, 17242010, 17242009, 17242008, 12107095, 12107094, 12107093, 12107092, 12107091, 18288014, 18288011, 17017003, 14090077, 13105148, 19095002, 13154208, 13154207, 13105146, 12285351, 12285350, 12219238, 12219233, 12053038, 12053036, 11339156, 11213084, 12240286, 12240285, 12240284, 12240283, 12240282, 12240281, 12240280, 12045030, 12045029, 10110062, 10110061, 10110060, 19192009, 19095005, 18054010, 18054009, 18054008, 17117050, 17117049, 17117048, 15327106, 15327105, 15327104, 15327103, 15327102, 15327101, 15320100, 15320099, 15320098, 15320097, 15320096, 15320095, 15320094, 15320093, 14251231, 14244229, 14244228, 13066086, 12205215, 11276128, 11276127, 9202053, 18255004, 18250010, 18172008, 13161218, 13105149, 13105145, 12219236, 12079064, 12079061, 11276121, 11276111, 11152052, 11152051, 10250123, 10250120, 10139083, 10139081, 10139080, 10099037, 14237220, 14237218, 14237216, 15040039, 15040038, 13099133, 13099132, 13099131, 12156156, 12156155, 17234007, 14090075, 14090074, 14090073, 13161219, 11276114, 11276113, 11276112, 10250121, 15327110, 14090076, 13042052, 13024038, 11250095, 11250094, 10182100, 13210280, 13210279, 18288012, 17017002, 13024037, 13024034, 12285353, 12285352, 12285349, 12223239, 12219237, 12219235, 12086071, 11186054, 11152053, 11152045, 10250122, 10139082 Model Number 10-0000-07R, Serial Numbers: 11186058, 9298111, 18255010, 17215009, 17096033, 16277053, 16125025, 15131079, 14191153, 13178234, 20094002, 19295001, 19260003, 19233003, 19206005, 19123005, 19123002, 19095013, 19095001, 19084015, 19084013, 19084012, 19084011, 19084001, 19072009, 19072006, 19057013, 19036003, 19036002, 18344008, 18344004, 18333001, 18318015, 18318009, 18299012, 18299008, 18299007, 18299003, 18288008, 18264008, 18264007, 18264006, 18264002, 18255015, 18255008, 18255006, 18250013, 18250008, 18235009, 18235007, 18235005, 18226013, 18226012, 18226011, 18226007, 18226001, 18214007, 18205006, 18191012, 18177012, 18172008, 18159015, 18159014, 18156011, 18150006, 18150004, 18150003, 18141007, 18128004, 18120008, 18099006, 18088005, 18088004, 18088003, 18072009, 18072005, 18072004, 18060010, 18060009, 18057009, 18046010, 18046005, 18046004, 18046003, 18046002, 18046001, 18039007, 18039005, 18039004, 18037005, 18037004, 18037003, 18037002, 18037001, 18026003, 18024002, 18023007, 18022003, 17347002, 17347001, 17340004, 17333001, 17307003, 17307001, 17296010, 17296009, 17296008, 17296007, 17296006, 17296005, 17284009, 17284006, 17284001, 17278001, 17262010, 17215008, 17215005, 17215001, 17177002, 17177001, 17130059, 17117044, 17096037, 17096035, 17096032, 17096031, 17062026, 16347084, 16299066, 16299062, 16299061, 16242043, 16242041, 16214036, 16077013, 16049002, 16049001, 15327109, 15208089, 15208088, 15208087, 15208081, 15131072, 15131071, 15096063, 15075060, 15075056, 15075053, 15075051, 15055046, 15055044, 15055042, 15040033, 15033025, 15033024, 15033022, 15033021, 15020018, 15020017, 15020016, 15020015, 15020014, 15020013, 15020012, 14322269, 14322267, 14322267, 14322262, 14322261, 14307260, 14307259, 14307258, 14307257, 14307256, 14265246, 14265245, 14265241, 14251240, 14251239, 14251238, 14251237, 14251234, 14251233, 14244230, 14244221, 14237215, 14230205, 14230204, 14230203, 14230202, 14224199, 14218181, 14211180, 14211177, 14211173, 14211172, 14191158, 14191157, 14191155, 14191154, 14182150, 14182149, 14182143, 14182142, 14177138, 14177137, 14177135, 14177134, 14155128, 14155124, 14155123, 14155122, 14155121, 14142116, 14142115, 14142114, 14142112, 14142111, 14139110, 14139109, 14139108, 14139107, 14139106, 14139104, 14139103, 14118093, 14118092, 14111087, 14111086, 14111084, 14111081, 14090079, 14083069, 14083068, 14083067, 14083066, 14083065, 14083064, 14083063, 14069060, 14069053, 14069052, 14069051, 14062050, 14062047, 14062042, 14062041, 14052036, 14052035, 14052034, 14052033, 14043030, 14043029, 14043028, 14043026, 14043024, 14043023, 14043022, 14006009, 14006001, 13315359, 13315358, 13315355, 13315354, 13315353, 13315351, 13301350, 13301347, 13301344, 13301341, 13274340, 13274337, 13274336, 13274335, 13274334, 13274332, 13245318, 13245315, 13245314, 13245313, 13245312, 13245311, 13238310, 13238309, 13238307, 13238306, 13238305, 13238304, 13238301, 13227296, 13224290, 13224288, 13224287, 13224285, 13224282, 13224281, 13210278, 13210277, 13210276, 13210275, 13210274, 13203270, 13203269, 13203265, 13203264, 13203263, 13203262, 13203261, 13193260, 13193258, 13193257, 13186249, 13186248, 13186247, 13186246, 13186245, 13186241, 13178240, 13178233, 13178232, 13178231, 13170229, 13170227, 13170226, 13170225, 13170224, 13161217, 13161216, 13161215, 13161214, 13161211, 13154210, 13154209, 13140197, 13140196, 13140195, 13140194, 13140193, 13140192, 13140191, 13133190, 13133189, 13133188, 13133187, 13133184, 13133182, 13127180, 13127174, 13127173, 13127172, 13127171, 13121166, 13121165, 13121164, 13121163, 13121162, 13121161, 13112160, 13112159, 13112152, 13112151, 13105150, 13099140, 13099139, 13099138, 13099137, 13092130, 13092129, 13092126, 13087116, 13087115, 13087114, 13087111, 13079110, 13079104, 13079103, 13079102, 13079101, 13072093, 13072092, 13072091, 13066089, 13066088, 13066085, 13066084, 13066081, 13060080, 13060074, 13051068, 13051067, 13051066, 13051064, 13051063, 13051062, 13042060, 13042059, 13037048, 13037041, 13024040, 13024039, 13018029, 13018028, 13018027, 13018024, 13008017, 13008014, 13008013, 13008011, 13003008, 13003003, 12340438, 12333428, 12333427, 12333426, 12324412, 12324411, 12317408, 12317407, 12317406, 12317404, 12317403, 12317400, 12310398, 12310396, 12310393, 12310392, 12310391, 12310390, 12310389, 12305384, 12305383, 12305381, 12303374, 12303373, 12303372, 12303371, 12303370, 12303369, 12292368, 12292363, 12292359, 12285358, 12285357, 12285356, 12278348, 12278347, 12278345, 12278344, 12278343, 12278342, 12278341, 12278339, 12271338, 12271337, 12271336, 12271335, 12271334, 12271333, 12271332, 12271331, 12271330, 12271329, 12268328, 12268327, 12268326, 12268323, 12261315, 12261313, 12254303, 12254302, 12254301, 12254300, 12254299, 12248298, 12248297, 12248295, 12248294, 12248293, 12248289, 12240288, 12240287, 12240279, 12236278, 12233265, 12233261, 12233260, 12229257, 12229256, 12229255, 12229254, 12229253, 12229250, 12229249, 12223248, 12223247, 12223246, 12223245, 12223244, 12223241, 12219230, 12219229, 12205214, 12205213, 12205212, 12205211, 12205210, 12205209, 12198208, 12198207, 12198206, 12198205, 12198204, 12198203, 12198202, 12198201, 12198200, 12198199, 12198198, 12198197, 12198196, 12175193, 12175192, 12175188, 12175187, 12175186, 12175185, 12175180, 12170178, 12170174, 12170167, 12156162, 12156161, 12145148, 12145147, 12145146, 12145145, 12142140, 12142139, 12142138, 12136135, 12136133, 12136132, 12136131, 12136129, 12128121, 12128120, 12128117, 12128116, 12128115, 12128114, 12128113, 12111107, 12111106, 12111105, 12111104, 12111103, 12111102, 12111101, 12107100, 12107096, 12088090, 12086077, 12086074, 12069058, 12069051, 12061049, 12061047, 12061044, 12053040, 12053035, 12053033, 12053032, 12053031, 12045025, 12045024, 12038020, 12038019, 12016010, 12016009, 12016008, 12016007, 12016006, 12016005, 11339155, 11339154, 11339150, 11306147, 11306146, 11306143, 11306140, 11306139, 11306138, 11306136, 11306134, 11276120, 11276119, 11276118, 11276117, 11276116, 11276115, 11276110, 11250104, 11250097, 11250092, 11250091, 11236088, 11236087, 11213086, 11213085, 11213083, 11213082, 11213077, 11213070, 11213069, 11213068, 11213067, 11186066, 11186065, 11186064, 11186060, 11186059, 11186057, 11122040, 11122039, 11122038, 11122037, 11122036, 11122035, 11101032, 11101031, 11101030, 11101029, 11101028, 11068022, 11068020, 11068019, 11068018, 11068017, 11040016, 11040015, 11040014, 11040012, 11040011, 11040010, 11040009, 11021008, 11021007, 11021006, 11021005, 11021004, 11021002, 11021001, 10350172, 10350171, 10350170, 10350169, 10350168, 10350167, 10350166, 10350165, 10336164, 10336163, 10336162, 10336161, 10336160, 10336159, 10336158, 10336157, 10336156, 10336155, 10295154, 10295153, 10295152, 10295151, 10295150, 10278134, 10278130, 10278129, 10278127, 10278126, 10278125, 10250124, 10250115, 10210114, 10210113, 10182099, 10182098, 10182097, 10162091, 10162090, 10162088, 10162086, 10139079, 10119077, 10119075, 10119072, 10110059, 10102045, 10099044, 10099043, 10099042, 10099041, 10099040, 10099039, 10099038, 10099036, 10099035, 10099031, 10099030, 10043026, 10043022, 10043021, 10035020, 10035019, 10035018, 10035014, 10035013, 10014011, 10014010, 10014009, 10014008, 10014007, 10014006, 10014005, 10014002, 9350166, 9336154, 9336153, 9336152, 9336151, 9336143, 9325142, 9325141, 9325140, 9325139, 9325137, 9313125, 9293110, 9293108, 9293107, 9293105, 9293104, 9288100, 9288099, 9288098, 9277087, 9270083, 9270081, 9270079, 9255076, 9202049, 9163036, 9163033, 9163032, 9135030, 9135023, 9121016, 9100013, 9100008, 10035017, D09288101, 15015004, 12079067, 11101026, 11101025, 11068024, 11068023, 10035016, 10035015

Recall number

Product, codes & lots

Z-0476-2021

Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.; UDI 00857573006010 Model Number 10-0000-07, Serial Numbers: 10110051, 10110050, 10110048, 10110047, 10099033, 10099032, 10099029, 10043027, 10043025, 10043024, 10043023, 10035106, 10035105, 10014003, 10014001, 9350165, 9350164, 9350163, 9350161, 9350160, 9350159, 9336156, 9336150, 9336149, 9336148, 9336147, 9336146, 9336145, 9336144, 9325152, 9325151, 9325138, 9320127, 9313124, 9313123, 9313122, 9313121, 9313120, 9313119, 9298118, 9298117, 9298116, 9293111, 9293109, 9293106, 9293103, 9288102, 9288097, 9288096, 9288095, 9277094, 9277093, 9277092, 9277091, 9277090, 9277089, 9277088, 9270087, 9270086, 9270085, 9270084, 9270082, 9270080, 9255080, 9255079, 9255077, 9255072, 9255071, 9230075, 9230074, 9230070, 9230069, 9230068, 9230067, 9230066, 9230065, 9230064, 9230063, 9210062, 9210061, 9210059, 9210058, 9210057, 9210056, 9202052, 9202047, 9163046, 9163045, 9163044, 9163044, 9163043, 9163042, 9163041, 9163040, 9163039, 9163038, 9163035, 9163034, 9135029, 9135028, 9135027, 9135026, 9121022, 9121021, 9121019, 9121018, 9121017, 9121015, 911, 9100014, 9100012, 9100011, 9100009, 9098006, 9098005, 9098003, 9098002, 9098001, 907, 902, 10035017R, 10014012 Correct, 10014012, D09336158, 9336158, D09336157, 9336157, D09135024, 9135024, D0912, 912, D0909, 909, D908, D0908, 908, 18255014, 18150007, 18120010, 18120003, 17333003, 17250008, 17250005, 17250002, 17130060, 17017006, 16334077, 13154206, 13154205, 13154204, 13154203, 13154202, 13008020, 12333423, 12324418, 12324417, 12324416, 12324415, 12324414, 12254308, 12254307, 12254306, 12254305, 12248296, 12333422, 12333420, 12333419, 20212005, 20007006, 20007005, 20007004, 20007002, 20007001, 19317003, 19317002, 19295003, 19095010, 19031003, 18333008, 18318006, 18264010, 18250012, 18250011, 18205003, 18191003, 18060006, 18060006, 17250007, 17234003, 17234002, 17234001, 17017001, 16277051, 15015004, 14211179, 14211178, 14211174, 13178239, 13178238, 13178237, 13178236, 13154201, 13140200, 13140199, 12086072, 12079070, 12079069, 12079065, 9298112, 9210055, 9202054, 12136125, 12128124, 12045028, 12045027, 12045026, 11250109, 11186056, 11186055, 11152050, 11152049, 11152048, 10102046, 18046009, 12061043, 12061042, 18026001, 17250010, 17250009, 19295006, 13105147, 13024036, 13024035, 13024033, 12219234, 12079068, 12079066, 11101027, 11276129, 17242010, 17242009, 17242008, 12107095, 12107094, 12107093, 12107092, 12107091, 18288014, 18288011, 17017003, 14090077, 13105148, 19095002, 13154208, 13154207, 13105146, 12285351, 12285350, 12219238, 12219233, 12053038, 12053036, 11339156, 11213084, 12240286, 12240285, 12240284, 12240283, 12240282, 12240281, 12240280, 12045030, 12045029, 10110062, 10110061, 10110060, 19192009, 19095005, 18054010, 18054009, 18054008, 17117050, 17117049, 17117048, 15327106, 15327105, 15327104, 15327103, 15327102, 15327101, 15320100, 15320099, 15320098, 15320097, 15320096, 15320095, 15320094, 15320093, 14251231, 14244229, 14244228, 13066086, 12205215, 11276128, 11276127, 9202053, 18255004, 18250010, 18172008, 13161218, 13105149, 13105145, 12219236, 12079064, 12079061, 11276121, 11276111, 11152052, 11152051, 10250123, 10250120, 10139083, 10139081, 10139080, 10099037, 14237220, 14237218, 14237216, 15040039, 15040038, 13099133, 13099132, 13099131, 12156156, 12156155, 17234007, 14090075, 14090074, 14090073, 13161219, 11276114, 11276113, 11276112, 10250121, 15327110, 14090076, 13042052, 13024038, 11250095, 11250094, 10182100, 13210280, 13210279, 18288012, 17017002, 13024037, 13024034, 12285353, 12285352, 12285349, 12223239, 12219237, 12219235, 12086071, 11186054, 11152053, 11152045, 10250122, 10139082 Model Number 10-0000-07R, Serial Numbers: 11186058, 9298111, 18255010, 17215009, 17096033, 16277053, 16125025, 15131079, 14191153, 13178234, 20094002, 19295001, 19260003, 19233003, 19206005, 19123005, 19123002, 19095013, 19095001, 19084015, 19084013, 19084012, 19084011, 19084001, 19072009, 19072006, 19057013, 19036003, 19036002, 18344008, 18344004, 18333001, 18318015, 18318009, 18299012, 18299008, 18299007, 18299003, 18288008, 18264008, 18264007, 18264006, 18264002, 18255015, 18255008, 18255006, 18250013, 18250008, 18235009, 18235007, 18235005, 18226013, 18226012, 18226011, 18226007, 18226001, 18214007, 18205006, 18191012, 18177012, 18172008, 18159015, 18159014, 18156011, 18150006, 18150004, 18150003, 18141007, 18128004, 18120008, 18099006, 18088005, 18088004, 18088003, 18072009, 18072005, 18072004, 18060010, 18060009, 18057009, 18046010, 18046005, 18046004, 18046003, 18046002, 18046001, 18039007, 18039005, 18039004, 18037005, 18037004, 18037003, 18037002, 18037001, 18026003, 18024002, 18023007, 18022003, 17347002, 17347001, 17340004, 17333001, 17307003, 17307001, 17296010, 17296009, 17296008, 17296007, 17296006, 17296005, 17284009, 17284006, 17284001, 17278001, 17262010, 17215008, 17215005, 17215001, 17177002, 17177001, 17130059, 17117044, 17096037, 17096035, 17096032, 17096031, 17062026, 16347084, 16299066, 16299062, 16299061, 16242043, 16242041, 16214036, 16077013, 16049002, 16049001, 15327109, 15208089, 15208088, 15208087, 15208081, 15131072, 15131071, 15096063, 15075060, 15075056, 15075053, 15075051, 15055046, 15055044, 15055042, 15040033, 15033025, 15033024, 15033022, 15033021, 15020018, 15020017, 15020016, 15020015, 15020014, 15020013, 15020012, 14322269, 14322267, 14322267, 14322262, 14322261, 14307260, 14307259, 14307258, 14307257, 14307256, 14265246, 14265245, 14265241, 14251240, 14251239, 14251238, 14251237, 14251234, 14251233, 14244230, 14244221, 14237215, 14230205, 14230204, 14230203, 14230202, 14224199, 14218181, 14211180, 14211177, 14211173, 14211172, 14191158, 14191157, 14191155, 14191154, 14182150, 14182149, 14182143, 14182142, 14177138, 14177137, 14177135, 14177134, 14155128, 14155124, 14155123, 14155122, 14155121, 14142116, 14142115, 14142114, 14142112, 14142111, 14139110, 14139109, 14139108, 14139107, 14139106, 14139104, 14139103, 14118093, 14118092, 14111087, 14111086, 14111084, 14111081, 14090079, 14083069, 14083068, 14083067, 14083066, 14083065, 14083064, 14083063, 14069060, 14069053, 14069052, 14069051, 14062050, 14062047, 14062042, 14062041, 14052036, 14052035, 14052034, 14052033, 14043030, 14043029, 14043028, 14043026, 14043024, 14043023, 14043022, 14006009, 14006001, 13315359, 13315358, 13315355, 13315354, 13315353, 13315351, 13301350, 13301347, 13301344, 13301341, 13274340, 13274337, 13274336, 13274335, 13274334, 13274332, 13245318, 13245315, 13245314, 13245313, 13245312, 13245311, 13238310, 13238309, 13238307, 13238306, 13238305, 13238304, 13238301, 13227296, 13224290, 13224288, 13224287, 13224285, 13224282, 13224281, 13210278, 13210277, 13210276, 13210275, 13210274, 13203270, 13203269, 13203265, 13203264, 13203263, 13203262, 13203261, 13193260, 13193258, 13193257, 13186249, 13186248, 13186247, 13186246, 13186245, 13186241, 13178240, 13178233, 13178232, 13178231, 13170229, 13170227, 13170226, 13170225, 13170224, 13161217, 13161216, 13161215, 13161214, 13161211, 13154210, 13154209, 13140197, 13140196, 13140195, 13140194, 13140193, 13140192, 13140191, 13133190, 13133189, 13133188, 13133187, 13133184, 13133182, 13127180, 13127174, 13127173, 13127172, 13127171, 13121166, 13121165, 13121164, 13121163, 13121162, 13121161, 13112160, 13112159, 13112152, 13112151, 13105150, 13099140, 13099139, 13099138, 13099137, 13092130, 13092129, 13092126, 13087116, 13087115, 13087114, 13087111, 13079110, 13079104, 13079103, 13079102, 13079101, 13072093, 13072092, 13072091, 13066089, 13066088, 13066085, 13066084, 13066081, 13060080, 13060074, 13051068, 13051067, 13051066, 13051064, 13051063, 13051062, 13042060, 13042059, 13037048, 13037041, 13024040, 13024039, 13018029, 13018028, 13018027, 13018024, 13008017, 13008014, 13008013, 13008011, 13003008, 13003003, 12340438, 12333428, 12333427, 12333426, 12324412, 12324411, 12317408, 12317407, 12317406, 12317404, 12317403, 12317400, 12310398, 12310396, 12310393, 12310392, 12310391, 12310390, 12310389, 12305384, 12305383, 12305381, 12303374, 12303373, 12303372, 12303371, 12303370, 12303369, 12292368, 12292363, 12292359, 12285358, 12285357, 12285356, 12278348, 12278347, 12278345, 12278344, 12278343, 12278342, 12278341, 12278339, 12271338, 12271337, 12271336, 12271335, 12271334, 12271333, 12271332, 12271331, 12271330, 12271329, 12268328, 12268327, 12268326, 12268323, 12261315, 12261313, 12254303, 12254302, 12254301, 12254300, 12254299, 12248298, 12248297, 12248295, 12248294, 12248293, 12248289, 12240288, 12240287, 12240279, 12236278, 12233265, 12233261, 12233260, 12229257, 12229256, 12229255, 12229254, 12229253, 12229250, 12229249, 12223248, 12223247, 12223246, 12223245, 12223244, 12223241, 12219230, 12219229, 12205214, 12205213, 12205212, 12205211, 12205210, 12205209, 12198208, 12198207, 12198206, 12198205, 12198204, 12198203, 12198202, 12198201, 12198200, 12198199, 12198198, 12198197, 12198196, 12175193, 12175192, 12175188, 12175187, 12175186, 12175185, 12175180, 12170178, 12170174, 12170167, 12156162, 12156161, 12145148, 12145147, 12145146, 12145145, 12142140, 12142139, 12142138, 12136135, 12136133, 12136132, 12136131, 12136129, 12128121, 12128120, 12128117, 12128116, 12128115, 12128114, 12128113, 12111107, 12111106, 12111105, 12111104, 12111103, 12111102, 12111101, 12107100, 12107096, 12088090, 12086077, 12086074, 12069058, 12069051, 12061049, 12061047, 12061044, 12053040, 12053035, 12053033, 12053032, 12053031, 12045025, 12045024, 12038020, 12038019, 12016010, 12016009, 12016008, 12016007, 12016006, 12016005, 11339155, 11339154, 11339150, 11306147, 11306146, 11306143, 11306140, 11306139, 11306138, 11306136, 11306134, 11276120, 11276119, 11276118, 11276117, 11276116, 11276115, 11276110, 11250104, 11250097, 11250092, 11250091, 11236088, 11236087, 11213086, 11213085, 11213083, 11213082, 11213077, 11213070, 11213069, 11213068, 11213067, 11186066, 11186065, 11186064, 11186060, 11186059, 11186057, 11122040, 11122039, 11122038, 11122037, 11122036, 11122035, 11101032, 11101031, 11101030, 11101029, 11101028, 11068022, 11068020, 11068019, 11068018, 11068017, 11040016, 11040015, 11040014, 11040012, 11040011, 11040010, 11040009, 11021008, 11021007, 11021006, 11021005, 11021004, 11021002, 11021001, 10350172, 10350171, 10350170, 10350169, 10350168, 10350167, 10350166, 10350165, 10336164, 10336163, 10336162, 10336161, 10336160, 10336159, 10336158, 10336157, 10336156, 10336155, 10295154, 10295153, 10295152, 10295151, 10295150, 10278134, 10278130, 10278129, 10278127, 10278126, 10278125, 10250124, 10250115, 10210114, 10210113, 10182099, 10182098, 10182097, 10162091, 10162090, 10162088, 10162086, 10139079, 10119077, 10119075, 10119072, 10110059, 10102045, 10099044, 10099043, 10099042, 10099041, 10099040, 10099039, 10099038, 10099036, 10099035, 10099031, 10099030, 10043026, 10043022, 10043021, 10035020, 10035019, 10035018, 10035014, 10035013, 10014011, 10014010, 10014009, 10014008, 10014007, 10014006, 10014005, 10014002, 9350166, 9336154, 9336153, 9336152, 9336151, 9336143, 9325142, 9325141, 9325140, 9325139, 9325137, 9313125, 9293110, 9293108, 9293107, 9293105, 9293104, 9288100, 9288099, 9288098, 9277087, 9270083, 9270081, 9270079, 9255076, 9202049, 9163036, 9163033, 9163032, 9135030, 9135023, 9121016, 9100013, 9100008, 10035017, D09288101, 15015004, 12079067, 11101026, 11101025, 11068024, 11068023, 10035016, 10035015

Z-0477-2021

Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.; UDI 00857573006010 Model Number 10-0000-07, Serial Numbers: 10110051, 10110050, 10110048, 10110047, 10099033, 10099032, 10099029, 10043027, 10043025, 10043024, 10043023, 10035106, 10035105, 10014003, 10014001, 9350165, 9350164, 9350163, 9350161, 9350160, 9350159, 9336156, 9336150, 9336149, 9336148, 9336147, 9336146, 9336145, 9336144, 9325152, 9325151, 9325138, 9320127, 9313124, 9313123, 9313122, 9313121, 9313120, 9313119, 9298118, 9298117, 9298116, 9293111, 9293109, 9293106, 9293103, 9288102, 9288097, 9288096, 9288095, 9277094, 9277093, 9277092, 9277091, 9277090, 9277089, 9277088, 9270087, 9270086, 9270085, 9270084, 9270082, 9270080, 9255080, 9255079, 9255077, 9255072, 9255071, 9230075, 9230074, 9230070, 9230069, 9230068, 9230067, 9230066, 9230065, 9230064, 9230063, 9210062, 9210061, 9210059, 9210058, 9210057, 9210056, 9202052, 9202047, 9163046, 9163045, 9163044, 9163044, 9163043, 9163042, 9163041, 9163040, 9163039, 9163038, 9163035, 9163034, 9135029, 9135028, 9135027, 9135026, 9121022, 9121021, 9121019, 9121018, 9121017, 9121015, 911, 9100014, 9100012, 9100011, 9100009, 9098006, 9098005, 9098003, 9098002, 9098001, 907, 902, 10035017R, 10014012 Correct, 10014012, D09336158, 9336158, D09336157, 9336157, D09135024, 9135024, D0912, 912, D0909, 909, D908, D0908, 908, 18255014, 18150007, 18120010, 18120003, 17333003, 17250008, 17250005, 17250002, 17130060, 17017006, 16334077, 13154206, 13154205, 13154204, 13154203, 13154202, 13008020, 12333423, 12324418, 12324417, 12324416, 12324415, 12324414, 12254308, 12254307, 12254306, 12254305, 12248296, 12333422, 12333420, 12333419, 20212005, 20007006, 20007005, 20007004, 20007002, 20007001, 19317003, 19317002, 19295003, 19095010, 19031003, 18333008, 18318006, 18264010, 18250012, 18250011, 18205003, 18191003, 18060006, 18060006, 17250007, 17234003, 17234002, 17234001, 17017001, 16277051, 15015004, 14211179, 14211178, 14211174, 13178239, 13178238, 13178237, 13178236, 13154201, 13140200, 13140199, 12086072, 12079070, 12079069, 12079065, 9298112, 9210055, 9202054, 12136125, 12128124, 12045028, 12045027, 12045026, 11250109, 11186056, 11186055, 11152050, 11152049, 11152048, 10102046, 18046009, 12061043, 12061042, 18026001, 17250010, 17250009, 19295006, 13105147, 13024036, 13024035, 13024033, 12219234, 12079068, 12079066, 11101027, 11276129, 17242010, 17242009, 17242008, 12107095, 12107094, 12107093, 12107092, 12107091, 18288014, 18288011, 17017003, 14090077, 13105148, 19095002, 13154208, 13154207, 13105146, 12285351, 12285350, 12219238, 12219233, 12053038, 12053036, 11339156, 11213084, 12240286, 12240285, 12240284, 12240283, 12240282, 12240281, 12240280, 12045030, 12045029, 10110062, 10110061, 10110060, 19192009, 19095005, 18054010, 18054009, 18054008, 17117050, 17117049, 17117048, 15327106, 15327105, 15327104, 15327103, 15327102, 15327101, 15320100, 15320099, 15320098, 15320097, 15320096, 15320095, 15320094, 15320093, 14251231, 14244229, 14244228, 13066086, 12205215, 11276128, 11276127, 9202053, 18255004, 18250010, 18172008, 13161218, 13105149, 13105145, 12219236, 12079064, 12079061, 11276121, 11276111, 11152052, 11152051, 10250123, 10250120, 10139083, 10139081, 10139080, 10099037, 14237220, 14237218, 14237216, 15040039, 15040038, 13099133, 13099132, 13099131, 12156156, 12156155, 17234007, 14090075, 14090074, 14090073, 13161219, 11276114, 11276113, 11276112, 10250121, 15327110, 14090076, 13042052, 13024038, 11250095, 11250094, 10182100, 13210280, 13210279, 18288012, 17017002, 13024037, 13024034, 12285353, 12285352, 12285349, 12223239, 12219237, 12219235, 12086071, 11186054, 11152053, 11152045, 10250122, 10139082 Model Number 10-0000-07R, Serial Numbers: 11186058, 9298111, 18255010, 17215009, 17096033, 16277053, 16125025, 15131079, 14191153, 13178234, 20094002, 19295001, 19260003, 19233003, 19206005, 19123005, 19123002, 19095013, 19095001, 19084015, 19084013, 19084012, 19084011, 19084001, 19072009, 19072006, 19057013, 19036003, 19036002, 18344008, 18344004, 18333001, 18318015, 18318009, 18299012, 18299008, 18299007, 18299003, 18288008, 18264008, 18264007, 18264006, 18264002, 18255015, 18255008, 18255006, 18250013, 18250008, 18235009, 18235007, 18235005, 18226013, 18226012, 18226011, 18226007, 18226001, 18214007, 18205006, 18191012, 18177012, 18172008, 18159015, 18159014, 18156011, 18150006, 18150004, 18150003, 18141007, 18128004, 18120008, 18099006, 18088005, 18088004, 18088003, 18072009, 18072005, 18072004, 18060010, 18060009, 18057009, 18046010, 18046005, 18046004, 18046003, 18046002, 18046001, 18039007, 18039005, 18039004, 18037005, 18037004, 18037003, 18037002, 18037001, 18026003, 18024002, 18023007, 18022003, 17347002, 17347001, 17340004, 17333001, 17307003, 17307001, 17296010, 17296009, 17296008, 17296007, 17296006, 17296005, 17284009, 17284006, 17284001, 17278001, 17262010, 17215008, 17215005, 17215001, 17177002, 17177001, 17130059, 17117044, 17096037, 17096035, 17096032, 17096031, 17062026, 16347084, 16299066, 16299062, 16299061, 16242043, 16242041, 16214036, 16077013, 16049002, 16049001, 15327109, 15208089, 15208088, 15208087, 15208081, 15131072, 15131071, 15096063, 15075060, 15075056, 15075053, 15075051, 15055046, 15055044, 15055042, 15040033, 15033025, 15033024, 15033022, 15033021, 15020018, 15020017, 15020016, 15020015, 15020014, 15020013, 15020012, 14322269, 14322267, 14322267, 14322262, 14322261, 14307260, 14307259, 14307258, 14307257, 14307256, 14265246, 14265245, 14265241, 14251240, 14251239, 14251238, 14251237, 14251234, 14251233, 14244230, 14244221, 14237215, 14230205, 14230204, 14230203, 14230202, 14224199, 14218181, 14211180, 14211177, 14211173, 14211172, 14191158, 14191157, 14191155, 14191154, 14182150, 14182149, 14182143, 14182142, 14177138, 14177137, 14177135, 14177134, 14155128, 14155124, 14155123, 14155122, 14155121, 14142116, 14142115, 14142114, 14142112, 14142111, 14139110, 14139109, 14139108, 14139107, 14139106, 14139104, 14139103, 14118093, 14118092, 14111087, 14111086, 14111084, 14111081, 14090079, 14083069, 14083068, 14083067, 14083066, 14083065, 14083064, 14083063, 14069060, 14069053, 14069052, 14069051, 14062050, 14062047, 14062042, 14062041, 14052036, 14052035, 14052034, 14052033, 14043030, 14043029, 14043028, 14043026, 14043024, 14043023, 14043022, 14006009, 14006001, 13315359, 13315358, 13315355, 13315354, 13315353, 13315351, 13301350, 13301347, 13301344, 13301341, 13274340, 13274337, 13274336, 13274335, 13274334, 13274332, 13245318, 13245315, 13245314, 13245313, 13245312, 13245311, 13238310, 13238309, 13238307, 13238306, 13238305, 13238304, 13238301, 13227296, 13224290, 13224288, 13224287, 13224285, 13224282, 13224281, 13210278, 13210277, 13210276, 13210275, 13210274, 13203270, 13203269, 13203265, 13203264, 13203263, 13203262, 13203261, 13193260, 13193258, 13193257, 13186249, 13186248, 13186247, 13186246, 13186245, 13186241, 13178240, 13178233, 13178232, 13178231, 13170229, 13170227, 13170226, 13170225, 13170224, 13161217, 13161216, 13161215, 13161214, 13161211, 13154210, 13154209, 13140197, 13140196, 13140195, 13140194, 13140193, 13140192, 13140191, 13133190, 13133189, 13133188, 13133187, 13133184, 13133182, 13127180, 13127174, 13127173, 13127172, 13127171, 13121166, 13121165, 13121164, 13121163, 13121162, 13121161, 13112160, 13112159, 13112152, 13112151, 13105150, 13099140, 13099139, 13099138, 13099137, 13092130, 13092129, 13092126, 13087116, 13087115, 13087114, 13087111, 13079110, 13079104, 13079103, 13079102, 13079101, 13072093, 13072092, 13072091, 13066089, 13066088, 13066085, 13066084, 13066081, 13060080, 13060074, 13051068, 13051067, 13051066, 13051064, 13051063, 13051062, 13042060, 13042059, 13037048, 13037041, 13024040, 13024039, 13018029, 13018028, 13018027, 13018024, 13008017, 13008014, 13008013, 13008011, 13003008, 13003003, 12340438, 12333428, 12333427, 12333426, 12324412, 12324411, 12317408, 12317407, 12317406, 12317404, 12317403, 12317400, 12310398, 12310396, 12310393, 12310392, 12310391, 12310390, 12310389, 12305384, 12305383, 12305381, 12303374, 12303373, 12303372, 12303371, 12303370, 12303369, 12292368, 12292363, 12292359, 12285358, 12285357, 12285356, 12278348, 12278347, 12278345, 12278344, 12278343, 12278342, 12278341, 12278339, 12271338, 12271337, 12271336, 12271335, 12271334, 12271333, 12271332, 12271331, 12271330, 12271329, 12268328, 12268327, 12268326, 12268323, 12261315, 12261313, 12254303, 12254302, 12254301, 12254300, 12254299, 12248298, 12248297, 12248295, 12248294, 12248293, 12248289, 12240288, 12240287, 12240279, 12236278, 12233265, 12233261, 12233260, 12229257, 12229256, 12229255, 12229254, 12229253, 12229250, 12229249, 12223248, 12223247, 12223246, 12223245, 12223244, 12223241, 12219230, 12219229, 12205214, 12205213, 12205212, 12205211, 12205210, 12205209, 12198208, 12198207, 12198206, 12198205, 12198204, 12198203, 12198202, 12198201, 12198200, 12198199, 12198198, 12198197, 12198196, 12175193, 12175192, 12175188, 12175187, 12175186, 12175185, 12175180, 12170178, 12170174, 12170167, 12156162, 12156161, 12145148, 12145147, 12145146, 12145145, 12142140, 12142139, 12142138, 12136135, 12136133, 12136132, 12136131, 12136129, 12128121, 12128120, 12128117, 12128116, 12128115, 12128114, 12128113, 12111107, 12111106, 12111105, 12111104, 12111103, 12111102, 12111101, 12107100, 12107096, 12088090, 12086077, 12086074, 12069058, 12069051, 12061049, 12061047, 12061044, 12053040, 12053035, 12053033, 12053032, 12053031, 12045025, 12045024, 12038020, 12038019, 12016010, 12016009, 12016008, 12016007, 12016006, 12016005, 11339155, 11339154, 11339150, 11306147, 11306146, 11306143, 11306140, 11306139, 11306138, 11306136, 11306134, 11276120, 11276119, 11276118, 11276117, 11276116, 11276115, 11276110, 11250104, 11250097, 11250092, 11250091, 11236088, 11236087, 11213086, 11213085, 11213083, 11213082, 11213077, 11213070, 11213069, 11213068, 11213067, 11186066, 11186065, 11186064, 11186060, 11186059, 11186057, 11122040, 11122039, 11122038, 11122037, 11122036, 11122035, 11101032, 11101031, 11101030, 11101029, 11101028, 11068022, 11068020, 11068019, 11068018, 11068017, 11040016, 11040015, 11040014, 11040012, 11040011, 11040010, 11040009, 11021008, 11021007, 11021006, 11021005, 11021004, 11021002, 11021001, 10350172, 10350171, 10350170, 10350169, 10350168, 10350167, 10350166, 10350165, 10336164, 10336163, 10336162, 10336161, 10336160, 10336159, 10336158, 10336157, 10336156, 10336155, 10295154, 10295153, 10295152, 10295151, 10295150, 10278134, 10278130, 10278129, 10278127, 10278126, 10278125, 10250124, 10250115, 10210114, 10210113, 10182099, 10182098, 10182097, 10162091, 10162090, 10162088, 10162086, 10139079, 10119077, 10119075, 10119072, 10110059, 10102045, 10099044, 10099043, 10099042, 10099041, 10099040, 10099039, 10099038, 10099036, 10099035, 10099031, 10099030, 10043026, 10043022, 10043021, 10035020, 10035019, 10035018, 10035014, 10035013, 10014011, 10014010, 10014009, 10014008, 10014007, 10014006, 10014005, 10014002, 9350166, 9336154, 9336153, 9336152, 9336151, 9336143, 9325142, 9325141, 9325140, 9325139, 9325137, 9313125, 9293110, 9293108, 9293107, 9293105, 9293104, 9288100, 9288099, 9288098, 9277087, 9270083, 9270081, 9270079, 9255076, 9202049, 9163036, 9163033, 9163032, 9135030, 9135023, 9121016, 9100013, 9100008, 10035017, D09288101, 15015004, 12079067, 11101026, 11101025, 11068024, 11068023, 10035016, 10035015

Based on the official FDA remedy

What to do — step by step

Check Model and Serial Numbers
Verify your device has model numbers 10-0000-07 or 10-0000-07R and matches the listed serial numbers in the recall.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution. US nationwide and Kuwait, Austria, United Kingdom, Spain, France, Chile, Japan, Netherlands, Greece, Italy, Thailand, Germany, Turkey” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 3.3 years after the firm started it.

Oct 13, 2020Firm started the recall
Nov 20, 2020FDA classified it Class II
Dec 2, 2020Published in FDA’s Enforcement Report
Jan 22, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Luminex recalls

Link to this recall

<a href="https://govinfonow.com/recall/64095-luminex-verigene-processor-sp-model-10-0000-07r-recall-unapproved">Luminex Verigene Processor SP Model 10-0000-07R Recall: Unapproved Test Fixtures Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0476-2021 (October 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0476-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.