Lower risk Medical device recall · FDA · Published August 19, 2019

BD FACSLyric Flow Cytometer Recall: Excessive Electronic Abort Counts with Trucount Tubes

BD Biosciences recalls BD FACSLyric Flow Cytometers (serial numbers listed) when used with BD Trucount Tubes due to potential false high cell counts affecting patient care decisions.

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

🇺🇸 FDA recall #Z-0074-2020Medical device BD Biosciences ›

Lower-risk recall

Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

Take action

Contact the company

Recalling firmBecton, Dickinson and Company, BD Biosciences2350 Qume Dr · San Jose, CA 95131-1812

✎ GovInfoNow plain-language explainer

BD Biosciences is recalling specific models of their FACSLyric Flow Cytometers when used with Trucount Tubes. This can cause inaccurate cell counts that might lead to incorrect medical decisions for HIV patients and others with weakened immune systems. Read more at govinfonow.com/recall/67150-bd-facslyric-flow-cytometer-recall-excessive-electronic-abort-counts-with.

Source Summary by GovInfoNow · govinfonow.com/recall/67150-bd-facslyric-flow-cytometer-recall-excessive-electronic-abort-counts-with · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0074-2020

Cite this page

“BD FACSLyric Flow Cytometer Recall: Excessive Electronic Abort Counts with Trucount Tubes.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67150-bd-facslyric-flow-cytometer-recall-excessive-electronic-abort-counts-with. Based on FDA recall #Z-0074-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0074-2020%22&limit=1).

The FDA announced on 2019-08-19 that Becton, Dickinson and Company, BD Biosciences is recalling BD FACSLyric Flow Cytometers when used with BD Trucount Tubes due to a hazard of falsely high absolute counts. The agency issued recall number Z-0074-2020 for the Class II device.

How to tell if you have it

BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029
Serial numbers: R663029000001, R663029000002, R663029000003, R663029000004, R663029000005, R663029000006, R663029000007, R663029000008, R663029000010, R663029000011, R663029000012, R663029000014, R663029000015, R663029000016, R663029000017, R663029000018, R663029000021, R663029000025, R663029000031, R659180000136, R659180000160, R659180000238

The hazard

According to the FDA, flow cytometers may experience excessive electronic abort counts when used with specific tubes, potentially resulting in falsely high absolute counts. This hazard may affect the initiation of prophylactic therapy for Opportunistic Infections in HIV patients and decisions regarding care for PID or immune-suppressed patients.

Context

GovInfoNow's records show Becton, Dickinson and Company, BD Biosciences has 10 other recalls on record since 2018-05-16. Other recent recalls of similar products include BD Multitest 6-Color TBNK Kit (2024-05-08), BD Biosciences CD11b APC (2023-10-25), and BD Multitest 6-Color TBNK Recall (2022-10-03). Other recent recalls of similar products include GVS TM SQ40S Blood Transfusion Filter Recall (2025-11-03), Exploro Fertility Test Recall (2025-11-22), and LH One Step Ovulation Test Device Recall (2025-11-22).

How to tell if you have this one

Check if your BD FACSLyric Flow Cytometer has serial numbers starting with R663029 or R659180 (as listed in the recall). The issue occurs only when using BD Trucount Tubes.

Brand
BD Biosciences
Category
Medical device

FDA recall event · 9 products

All 9 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
U.S.: CA, KS, NJ, MI, NY, PA, IL, IN, VA, WA, MD, IA, OK, RI, FL, CO, OH, TX, TN, GA, MO, MN, HI, VT, MA, NE. O.U.S. (Foreign): Germany, Italy, South Korea, Japan, United Kingdom, Poland, France, Belgium, Canada, Latvia, India, Taiwan, Ireland, Algeria, Israel, Iraq, Netherlands, Malaysia, Australia, Sweden, Colombia, Switzerland, Slovakia, Spain, Brazil, Austria, Peru, Iran, Croatia, Lithuania, Czech Republic, Saudi Arabia, Finland, Qatar, South Africa, Denmark, Turkey, Mexico, Indonesia, Ecuador, Vietnam, Singapore

Recall number	Product, codes & lots	Quantity
Z-0066-2020	BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes; BD FACSLyric Flow Cytometer serial numbers: Z662875000001, Z662875000007, Z662875000008, Z662875000009, Z662875000011, Z662875000012, Z662875000013, Z662875000014, Z662875000015, Z662875000016, Z662875000017, Z662875000018.	12
Z-0067-2020	BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes; BD FACSLyric Flow Cytometer serial number: Z662876000007.	1
Z-0068-2020	BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes; BD FACSLyric Flow Cytometer serial numbers: Z662877000001, Z662877000002, Z662877000003, Z662877000004, Z662877000005, Z662877000006, Z662877000007, Z662877000008.	8
Z-0069-2020	BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes; BD FACSLyric Flow Cytometer serial numbers: Z662878000003, Z662878000041, Z662878000042, Z662878000043, Z662878000044, Z662878000045, Z662878000046, Z662878000047, Z662878000049, Z662878000050, Z662878000051, Z662878000052, Z662878000053, Z662878000054, Z662878000055, Z662878000056, Z662878000057, Z662878000058, Z662878000059, Z662878000060, Z662878000061, Z662878000062, Z662878000063, Z662878000064, Z662878000065, Z662878000066, Z662878000067, Z662878000068, Z662878000069, Z662878000070, Z662878000071, Z662878000072, Z662878000073, Z662878000074, Z662878000075, Z662878000076, Z662878000077, Z662878000078, Z662878000079, Z662878000080, Z662878000081, Z662878000082, Z662878000083, Z662878000084, Z662878000085, Z662878000086, Z662878000087, Z662878000088, Z662878000089, Z662878000090, Z662878000091, Z662878000092, Z662878000093, Z662878000094, Z662878000095, Z662878000096, Z662878000097, Z662878000098, Z662878000105, Z662878000106, Z662878000107, Z662878000108, Z662878000109, Z662878000110, Z662878000111, Z662878000112, Z662878000113, Z662878000114, Z662878000115, Z662878000116, Z662878000117, Z662878000118, Z662878000119, Z662878000120, Z662878000121, Z662878000122, Z662878000123, Z662878000048.	78
Z-0070-2020	BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes; BD FACSLyric Flow Cytometer serial numbers: R651164000007, R651164000016, R651164000017, R651164000019, R651164000020, R651164000021, R651164000022, R651164000023, R651164000024, R651164000025, R651164000026, R651164000027, R651164000028, R651164000029, R651164000030, R651164000031, R651164000032, R651164000033, R651164000034, R651164000035, R651164000036.	21
Z-0071-2020	BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes; BD FACSLyric Flow Cytometer serial numbers: R651165000010, R651165000023, R651165000024, R651165000025, R651165000026, R651165000027, R651165000028, R651165000029, R651165000030, R651165000031, R651165000032, R651165000033, R651165000034, R651165000035, R651165000036, R651165000037, R651165000038, R651165000039, R651165000040, R651165000041, R651165000042, R651165000043, R651165000044, R651165000045, R651165000046, R651165000048, R651165000049, R651165000050, R651165000051, R651165000052, R651165000053, R651165000054, R651165000055, R651165000057, R651165000058, R651165000060.	36
Z-0072-2020	BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes; BD FACSLyric Flow Cytometer serial numbers: R654587000008, R654587000009, R654587000010, R654587000011, R654587000024, R654587000026, R654587000027, R654587000028, R654587000029, R654587000030, R654587000031, R654587000032, R654587000033, R654587000034, R654587000035, R654587000036, R654587000037, R654587000038, R654587000039, R654587000040, R654587000041, R654587000042, R654587000043, R654587000044, R654587000045, R654587000046, R654587000047, R654587000048, R65458700020, Z654587P027.	30
Z-0073-2020	BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes; BD FACSLyric Flow Cytometer serial numbers: 9180000057, 9180000219, 9180000283, 0000001R6591800, R658180000282, R6591800000082, R6591800000083, R659180000045, R659180000051, R659180000061, R659180000063, R659180000064, R659180000068, R659180000071, R659180000075, R659180000089, R659180000099, R659180000137, R659180000167, R659180000196, R659180000202, R659180000204, R659180000211, R659180000213, R659180000229, R659180000230, R659180000231, R659180000232, R659180000233, R659180000234, R659180000235, R659180000236, R659180000237, R659180000239, R659180000240, R659180000241, R659180000242, R659180000243, R659180000244, R659180000245, R659180000246, R659180000247, R659180000248, R659180000249, R659180000250, R659180000251, R659180000252, R659180000253, R659180000254, R659180000255, R659180000256, R659180000257, R659180000258, R659180000259, R659180000260, R659180000261, R659180000262, R659180000263, R659180000264, R659180000265, R659180000266, R659180000267, R659180000268, R659180000269, R659180000270, R659180000272, R659180000273, R659180000274, R659180000275, R659180000276, R659180000277, R659180000278, R659180000279, R659180000280, R659180000281, R659180000282, R659180000283, R659180000284, R659180000285, R659180000286, R659180000287, R659180000288, R659180000289, R659180000290, R659180000291, R659180000292, R659180000293, R659180000294, R659180000295, R659180000296, R659180000297, R659180000298, R659180000299, R659180000300, R659180000301, R659180000302, R659180000303, R659180000304, R659180000305, R659180000306, R659180000307, R659180000311, R659180000312, R659180000313, R659180000314, R659180000315, R659180000316, R659180000317, R659180000318, R659180000319, R659180000321, R659180000322, R659180000323, R659180000324, R659180000325, R659180000326, R659180000327, R659180000328, R659180000329, R659180000330, R659180000331, R659180000332, R659180000333, R659180000334, R659180000335, R659180000336, R659180000337, R659180000338, R659180000339, R659180000340, R659180000341, R659180000342, R659180000343, R659180000344, R659180000345, R659180000346, R659180000347, R659180000348, R659180000349, R659180000350, R659180000352, R659180000353, R659180000354, R659180000355, R659180000356, R659180000357, R659180000358, R659180000359, R659180000360, R659180000361, R659180000362, R659180000363, R659180000364, R659180000365, R659180000366, R659180000367, R659180000368, R659180000369, R659180000370, R659180000371, R659180000372, R659180000373, R659180000374, R659180000375, R659180000376, R659180000377, R659180000378, R659180000379, R659180000380, R659180000381, R659180000382, R659180000383, R659180000384, R659180000385, R659180000386, R659180000387, R659180000388, R659180000389, R659180000390, R659180000391, R659180000392, R659180000393, R659180000394, R659180000395, R659180000396, R659180000397, R659180000398, R659180000399, R659180000402, R659180000403, R659180000404, R659180000405, R659180000406, R659180000407, R659180000408, R659180000409, R659180000410, R659180000411, R659180000412, R659180000413, R659180000414, R659180000415, R659180000416, R659180000417, R659180000418, R659180000419, R659180000420, R659180000422, R659180000423, R659180000424, R659180000425, R659180000426, R659180000427, R659180000428, R659180000430, R659180000431, R659180000432, R659180000433, R659180000435, R659180000436, R659180000438, R659180000442, R659180000445, R65918000084, R6591800022, R65918000314, R6591800038,2, RZ6591800026, Z651165P024, Z654587P006, Z654587P007, Z654587P018, Z654587P019, Z6591800013, Z66238300002, R659180000164.	236
Z-0074-2020	BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes; BD FACSLyric Flow Cytometer serial numbers: R663029000001, R663029000002, R663029000003, R663029000004, R663029000005, R663029000006, R663029000007, R663029000008, R663029000010, R663029000011, R663029000012, R663029000014, R663029000015, R663029000016, R663029000017, R663029000018, R663029000021, R663029000025, R663029000031, R659180000136, R659180000160, R659180000238.	22

Based on the official FDA remedy

What to do — step by step

Check Cytometer Serial Number
Verify your flow cytometer's serial number against the list of affected units provided in the recall notice.
Stop Using with Trucount Tubes
Do not use the recalled flow cytometers with BD Trucount Tubes until a confirmed fix is implemented.

Where it went and when

Where it was distributed

Distributed in 26 states, and outside the U.S.

FDA distribution: “U.S.: CA, KS, NJ, MI, NY, PA, IL, IN, VA, WA, MD, IA, OK, RI, FL, CO, OH, TX, TN, GA, MO, MN, HI, VT, MA, NE. O.U.S. (Foreign): Germany, Italy, South Korea, Japan, United Kingdom, Poland, France, Belgium, Canada, Latvia, India, Taiwan,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, Washington.

Recall timeline

FDA terminated this recall 4.6 years after the firm started it.

Aug 19, 2019Firm started the recall
Oct 9, 2019FDA classified it Class II
Oct 16, 2019Published in FDA’s Enforcement Report
Apr 12, 2024FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this a safety hazard?

This is a technical issue that could affect medical accuracy but does not pose a direct safety risk like fire or injury. The hazard level is low risk.

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Link to this recall

<a href="https://govinfonow.com/recall/67150-bd-facslyric-flow-cytometer-recall-excessive-electronic-abort-counts-with">BD FACSLyric Flow Cytometer Recall: Excessive Electronic Abort Counts with Trucount Tubes (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-0074-2020 (August 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0074-2020 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.