CLASS II Device recall · Reported 16 Oct 2019 · FDA Enforcement Report

BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument recalled

Becton, Dickinson and Company, BD Biosciences is recalling BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, distributed in 26 states. The recall was initiated on 19 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBD 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.

Quantity recalled78

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0069-2020
FDA event ID: 83603
Recalling firm: Becton, Dickinson and Company, BD Biosciences, San Jose, CA
Classification: Class II
Status: Terminated
Recall initiated: 19 Aug 2019
FDA classified: 9 Oct 2019
Reported: 16 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

19 Aug 2019	Recall initiated by company
9 Oct 2019	Classified by FDA	+51 days
16 Oct 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes

Where it was distributed

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

California Colorado Florida Georgia Hawaii Iowa Illinois Indiana Kansas Massachusetts Maryland Michigan Minnesota Missouri Nebraska New Jersey New York Ohio Oklahoma Pennsylvania

Questions about this recall

Why was it recalled?

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 83603

This product is part of a recall event; the main page for the event is BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument recalled.

Reported	Class	Recall	Company	Reason	Where
16 Oct 2019	CLASS II	BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument recalled	Becton, Dickinson and Company, BD Biosciences	Potency & Assay	26 states
16 Oct 2019	CLASS II	BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument recalled	Becton, Dickinson and Company, BD Biosciences	Potency & Assay	26 states
16 Oct 2019	CLASS II	BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument recalled	Becton, Dickinson and Company, BD Biosciences	Potency & Assay	26 states
16 Oct 2019	CLASS II	BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument recalled	Becton, Dickinson and Company, BD Biosciences	Potency & Assay	26 states
16 Oct 2019	CLASS II	BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument recalled	Becton, Dickinson and Company, BD Biosciences	Potency & Assay	26 states
16 Oct 2019	CLASS II	BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument recalled	Becton, Dickinson and Company, BD Biosciences	Potency & Assay	26 states
16 Oct 2019	CLASS II	BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument recalled	Becton, Dickinson and Company, BD Biosciences	Potency & Assay	26 states
16 Oct 2019	CLASS II	BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument recalled	Becton, Dickinson and Company, BD Biosciences	Potency & Assay	26 states

More recalls from Becton, Dickinson and Company, BD Biosciences

All 35

Reported	Class	Recall	Company	Reason	Where
24 Jul 2024Device	CLASS II	BD Multitest 6-Color Tbnk Ce-ivd recalled by Becton, Dickinson and	Becton, Dickinson and Company, BD Biosciences	Other	34 states
17 Jan 2024Device	CLASS II	CD11b APC: ASR recalled by Becton, Dickinson and	Becton, Dickinson and Company, BD Biosciences	Other	Nationwide
9 Nov 2022Device	CLASS II	BD Trucount Tubes recalled by Becton, Dickinson and	Becton, Dickinson and Company, BD Biosciences	Other	43 states
9 Nov 2022Device	CLASS II	BD Trucount Tubes recalled by Becton, Dickinson and	Becton, Dickinson and Company, BD Biosciences	Other	43 states
9 Nov 2022Device	CLASS II	BD Multitest 6-Color TBNK with optional BD Trucount Tubes recalled	Becton, Dickinson and Company, BD Biosciences	Other	43 states

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