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Lower risk Medical device recall · FDA · Published November 9, 2022

Biomerieux TSA 10PLT Recall: Temperature Issues May Affect Performance

Biomerieux recalls TSA 10PL: Temperature and time out of range may cause performance issues. Affected units have specific batch numbers and catalog codes.

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

🇺🇸 FDA recall #Z-0873-2023Medical deviceBiomerieux ›
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Contact the company

Recalling firmBiomerieux Inc595 Anglum Rd · Hazelwood, MO 63042-2320
✎ GovInfoNow plain-language explainer

Biomerieux is recalling TSA 10PLT products due to potential performance issues from temperature and time exposure. This could affect the product's reliability if stored or used outside recommended conditions. Read more at govinfonow.com/recall/59388-biomerieux-tsa-10plt-recall-temperature-issues-may-affect-performance.

Source Summary by GovInfoNow · govinfonow.com/recall/59388-biomerieux-tsa-10plt-recall-temperature-issues-may-affect-performance · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0873-2023

Cite this page

“Biomerieux TSA 10PLT Recall: Temperature Issues May Affect Performance.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59388-biomerieux-tsa-10plt-recall-temperature-issues-may-affect-performance. Based on FDA recall #Z-0873-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0873-2023%22&limit=1).

The FDA announced on November 9, 2022, that Biomerieux Inc voluntarily recalled PPM LOMBARD PRODUCTS TSA 10PLT, catalog M1040, because exceeded temperature and time ranges prevent product performance guarantees. The agency issued recall number Z-0873-2023 for the Class II device distributed nationwide.

How to tell if you have it

  • Brand: Biomerieux
  • Product: PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
  • UDI/DI: 03573026320362
  • Batch Numbers: 1009527240

The hazard

According to the FDA, when temperature and time out of range are exceeded, product performances cannot be guaranteed. The recall involves one unit distributed nationwide.

Context

GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since July 12, 2017. Recent brand recalls include the VITEK 2 AST-N461 Test Kit Recall dated July 24, 2026, and the VITEK 2 AST-N447 Kit Recall dated June 4, 2026. Other recent recalls of similar products include the Covidien Mon-a-Therm Temperature Probe Recall (April 23, 2026) and Medline Convenience Kits Recalls (May 28, 2026).

How to tell if you have this one

Check for the catalog code M1040 and batch number 1009527240 on the product label. The product is sold under the brand Biomerieux.

  • Brand
    Biomerieux
  • Category
    Medical device
FDA recall event · 94 products

All 94 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
    Ongoing
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-0783-2023API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300; UDI/DI 03573026035587, Batch Number 10094182805 unit
Z-0784-2023API 20 E 25 STRIPS, CATALOG 20100; UDI/DI 03573026047818, Batch Number 10092265601 unit
Z-0785-2023API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210; UDI/DI 03573026048082, Batch Number 10093736801 unit
Z-0786-2023API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500; UDI/DI 03573026048259, Batch Number 10093955301 unit
Z-0787-2023VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341; UDI/DI 03573026131913, Batch Numbers: 2412101403, 2412103403, 2412103503, 2412106403348 units
Z-0788-2023VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342; UDI/DI 03573026131920, Batch Numbers: 2422281503, 2422288503144 units
Z-0789-2023VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343; UDI/DI 03573026131937, Batch Numbers: 243226110314 units
Z-0790-2023VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345; UDI/DI 353026131951, Batch Numbers: 23921952031 unit
Z-0791-2023VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346; UDI/DI 03573026144357, Batch Numbers: 245227820313 units
Z-0792-2023VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226; UDI/DI 03573026242060, Batch Numbers: 132225840315 units
Z-0793-2023PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586; UDI/DI 03573026263140, Batch Numbers: 23043810 units
Z-0794-2023PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588; UDI/DI 03573026263164, Batch Numbers: 2294781 unit
Z-0795-2023VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217; UDI/DI 03573026064518, Batch Numbers: 2294782 units
Z-0796-2023VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219; UDI/DI 03573026064532, Batch Numbers: 10094218105 units
Z-0797-2023VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226; UDI/DI 03573026138585, Batch Numbers: 10093708502 units
Z-0798-2023VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700; UDI/DI 03573026065850, Batch Numbers: 100937114010 units
Z-0799-2023VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702; UDI/DI 03573026065874, Batch Numbers: 100940653015 units
Z-0800-2023VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706; UDI/DI 03573026121631, Batch Numbers: 100935156012 units
Z-0801-2023PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631; UDI/DI 03573026118969, Batch Numbers: 100953235010 units
Z-0802-2023PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841; UDI/DI 03573026313111, Batch Numbers: 1009525720, 100953005084 units
Z-0803-2023PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851; UDI/DI 03573026313128, Batch Numbers: 10095404001 unit
Z-0804-2023PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871; UDI/DI 03573026316969, Batch Numbers: 10095014301 unit
Z-0805-2023BIOBALL A.BRASILIENSIS NCPF 2275 550X20, CATALOG 56011; UDI/DI 03573026228194, Batch Numbers: 71122 units
Z-0806-2023BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012; UDI/DI 03573026228200, Batch Numbers: 71902 units
Z-0807-2023BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017; UDI/DI 03573026228255, Batch Numbers: 72402 units
Z-0808-2023API VP1 VP2 REAGENTS, CATALOG 70422; UDI/DI 03573026099626, Batch Numbers: 10093934501 unit
Z-0809-2023API NIT1 NIT2 REAGENTS, CATALOG 70442; UDI/DI 03573026099671, Batch Numbers: 10093265201 unit
Z-0810-2023API JAMES 2AMP, CATALOG 70542; UDI/DI 03573026099893, Batch Numbers: 10093605101 unit
Z-0811-2023TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000; UDI/DI 03573026128142, Batch Numbers: 10094779002 units
Z-0812-2023ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016; UDI/DI 03573026565541, Batch Numbers: 21EQC0163I, 21EQC0162I, 21EQC0160I, 21EQC0158I, 21EQC0174I5 units
Z-0813-2023PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849; UDI/DI 03573026357849, Batch Numbers: 2117760, 21201004 units
Z-0814-2023VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893; UDI/DI 03573026359096, Batch Numbers: 11111288BM13 units
Z-0815-2023VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071; UDI/DI 03573026362836, Batch Numbers: 1009391190, 1009434380, 100947210046 units
Z-0816-2023VITEK MS CLINICAL REAGENT VITEK MS-FA, CATALOG 411072; UDI/DI 03573026362843, Batch Numbers: 100934619029 units
Z-0817-2023ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218; UDI/DI 03573026376567, Batch Numbers: 1009209480N/A
Z-0818-2023ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240; UDI/DI 03573026376581, Batch Numbers: 10091905602 units
Z-0819-2023ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252; UDI/DI 03573026376703, Batch Numbers: 10093119202 units
Z-0820-2023ETEST CLINICAL BENZYLPENICIL PG 256 US S30, CATALOG 412262; UDI/DI 03573026376802, Batch Numbers: 10094779802 units
Z-0821-2023ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302; UDI/DI 03573026377205, Batch Numbers: 10094443401 unit
Z-0822-2023ETEST CLINICAL ERTAPENEM ETP 32 US S30, CATALOG 412331; UDI/DI 03573026377533, Batch Numbers: 10094918305 units
Z-0823-2023ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333; UDI/DI 03573026377557, Batch Numbers: 10091570905 units
Z-0824-2023ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333; UDI/DI 03573026377717, Batch Numbers: 10091720202 units
Z-0825-2023ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373; UDI/DI 03573026377953, Batch Numbers: 10093717802 units
Z-0826-2023ETEST CLINICAL LEVOFLOXACIN LE 32 US S30, CATALOG 412392; UDI/DI 03573026378073, Batch Numbers: 10092400007 units
Z-0827-2023ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401; UDI/DI 03573026378165, Batch Numbers: 03573026378165, 035730263781653 units
Z-0828-2023ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407; UDI/DI 03573026378226, Batch Numbers: 10094340003 units
Z-0829-2023ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449; UDI/DI 03573026378592, Batch Numbers: 10091906202 units
Z-0830-2023ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478; UDI/DI 03573026378875, Batch Numbers: 10094341604 units
Z-0831-2023ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486; UDI/DI 03573026378950, Batch Numbers: 10094321507 units
Z-0832-2023BIOBALL K.RHIZOPHILA (30X20), CATALOG 412690; UDI/DI 03573026381103, Batch Numbers: 74082 units
Z-0833-2023VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400; UDI/DI 03573026398460, Batch Numbers: 589225610330 units
Z-0834-2023VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401; UDI/DI 03573026398477, Batch Numbers: 5902225503, 5902279403120 units
Z-0835-2023VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404; UDI/DI 03573026398507, Batch Numbers: 593223740364 units
Z-0836-2023VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436; UDI/DI 03573026399016, Batch Numbers: 5992201403, 5992253503310 units
Z-0837-2023VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437; UDI/DI 03573026399023, Batch Numbers: 670223950315 units
Z-0838-2023VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438; UDI/DI 03573026399030, Batch Numbers: 671225740334 units
Z-0839-2023PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012; UDI/DI 03573026409913 , Batch Numbers: 21470801 unit
Z-0840-2023GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057; UDI/DI 3573026387761, Batch Numbers: 10093349902 units
Z-0841-2023ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445; UDI/DI 03573026418748, Batch Numbers: 10094204606 units
Z-0842-2023PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524; UDI/DI 03573026420758, Batch Numbers: 10095503106 units
Z-0843-2023VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670; UDI/DI 03573026437183, Batch Numbers: 2752252403218 units
Z-0844-2023PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049; UDI/DI 03573026466435, Batch Numbers: 10094629008 units
Z-0845-2023PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014; UDI/DI 03573026493868, Batch Numbers: 10094981407 units
Z-0846-2023ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046; UDI/DI 03573026494537, Batch Numbers: 10093844908 units
Z-0847-2023PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751; UDI/DI 03573026505684, Batch Numbers: 10095341706 units
Z-0848-2023VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915; UDI/DI 03573026552152, Batch Numbers: 541223720339 units
Z-0849-2023ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927; UDI/DI 03573026551544, Batch Numbers: 10089881702 units
Z-0850-2023VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051; UDI/DI 03573026553982, Batch Numbers: 278222550326 units
Z-0851-2023ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553; UDI/DI 03573026560997, Batch Numbers: 10092880502 units
Z-0852-2023ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560; UDI/DI 03573026560690, Batch Numbers: 10088486906 units
Z-0853-2023VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982; UDI/DI 03573026565923, Batch Numbers: 685224550384 units
Z-0854-2023VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS, CATALOG 423102; UDI/DI 03573026608132, Batch Numbers: 6892251103187 units
Z-0855-2023GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105; UDI/DI 03573026608514, Batch Numbers: 10094072502 units
Z-0856-2023VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416; UDI/DI 03573026618834, Batch Numbers: 41214850464 units
Z-0857-2023VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425; UDI/DI 03573026618940, Batch Numbers: 312225311350 units
Z-0858-2023PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723; UDI/DI 03573026618018, Batch Numbers: 100955266074 units
Z-0859-2023ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786; UDI/DI 03573026618766, Batch Numbers: 10094622901 unit
Z-0860-2023ETEST CLINICAL ETEST VANCOMYCIN VA M100 US, CATALOG 423788; UDI/DI 03573026618780, Batch Numbers: 10093515502 units
Z-0861-2023VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829; UDI/DI 03573026620288, Batch Numbers: 831224320358 units
Z-0862-2023ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013; UDI/DI 03573026565503, Batch Numbers: 22LCK0024G3 units
Z-0863-2023ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348; UDI/DI 03573026254681, Batch Numbers: 1009261260, Research use only1 unit
Z-0864-2023VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01; UDI/DI 03573026156923, Batch Numbers: 10095277704 units
Z-0865-2023VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01; UDI/DI 03573026156930, Batch Numbers: 10094833804 units
Z-0866-2023VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01; UDI/DI 03573026156954, Batch Numbers: 10093759606 units
Z-0867-2023VIDAS CLINICAL VIDAS ESTRADIOL II 60 TESTS, CATALOG 30431-01; UDI/DI 03573026161637, Batch Numbers: 10093786807 units
Z-0868-2023VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01; UDI/DI 03573026223601, Batch Numbers: 100930153047 units
Z-0869-2023DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01; UDI/DI 03661901000857, Batch Numbers: 307309014 units
Z-0870-2023PPM INDUSTRY COMBOURG BACARA 20PLATES 90MM, CATALOG AEB520100; UDI/DI 03661901005531, Batch Numbers: 213434010 units
Z-0871-2023PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR; UDI/DI 03573026319946, Batch Numbers: 100952432060 units
Z-0872-2023PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI; UDI/DI 03573026319953, Batch Numbers: 100938993020 units
Z-0873-2023PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040; UDI/DI 03573026320362, Batch Numbers: 10095272401 unit
Z-0874-2023PPM LOMBARD PRODUCTS R2A MEDIUM 10PLT, CATALOG M1065; UDI/DI 03573026320485, Batch Numbers: 100952729020 units
Z-0875-2023PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR; UDI/DI 03573026320706, Batch Numbers: 100949792012 units
Z-0876-2023PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035; UDI/DI 03573026321420, Batch Numbers: 1009564750100 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the catalog code M1040 and batch number 1009527240 on the product label.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Nov 9, 202212. FDA classified it Class II: Jan 4, 202323. Published in FDA’s Enforcement Report: Jan 11, 2023320222023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-0873-2023 (November 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0873-2023 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA