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Device recall: BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flo

FDA enforcement event 81915 · Class III · initiated 2 Jan 2019 · status Terminated · terminated 7 May 2021

DeviceVoluntary: Firm initiated1 product recordSan Jose, CA

FDA enforcement event 81915 is a device recall by Becton, Dickinson and Company, BD Biosciences of San Jose, CA, initiated 2 Jan 2019 and classified Class III, with 1 product record.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 6% of the 968 device enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 7 May 2021. Initiation: voluntary: firm initiated. Becton, Dickinson and Company, BD Biosciences has 22 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Becton, Dickinson and Company, BD Biosciences, San Jose, CA.

Reason for recall

"A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating system (OS). Windows 10 OS is not a released configuration for clinical use. It is released for research use only."

Distribution

"US Distribution in MD."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0792-2019	BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support of cell analysis. BD FACSuite software is…	3 devices	Class III	Terminated	13 Feb 2019

Context

6%of 2019 device events are Class III968 events that year

1product record in this eventfirm median: 1

22events on this register for the firm

Other enforcement events for Becton, Dickinson and Company, BD Biosciences

Initiated	Product (first record)	Type	Class	Records
8 May 2024	BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166;	Device	Class II	1
25 Oct 2023	CD11b APC: ASR, REF: 340936, and CE, REF: 333143	Device	Class II	1
3 Oct 2022	BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are	Device	Class II	3
25 Mar 2022	BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, which specifically recog	Device	Class II	2
22 Jul 2021	BD" Mouse IgG2a Isotype Control APC X39 ASR	Device	Class II	1
5 Oct 2020	BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping	Device	Class II	1
31 Mar 2020	Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (	Device	Class II	1
19 Aug 2019	BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes	Device	Class II	9
8 Jul 2019	BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical soft	Device	Class II	3
16 May 2018	BD FACS Universal Loader (Optional) to the BD FACSLyric Clinical System, Model 662879 (Universal Loader), Rx Only. The f	Device	Class III	1

All 22 events for Becton, Dickinson and Company, BD Biosciences

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating system (OS). Windows 10 OS is not a released configuration for clinical use. It is released for research use only."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "US Distribution in MD."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 7 May 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.