Lower riskMedical device recall · FDA · Published January 2, 2019
BD FACSLyric 3L 10C with FACSuite v1.1.1: Windows 10 Not Approved for Clinical Use
BD Biosciences recalls BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1 due to Windows 10 OS not being approved for clinical use. Affected units have specific serial numbers and catalog numbers.
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.
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 BD FACSLyric 3L 10C flow cytometers with FACSuite Clinical Software v1.1.1 because Windows 10 is not approved for clinical use. This could lead to improper testing results or safety issues if used in medical settings. Read more at govinfonow.com/recall/69193-bd-facslyric-3l-10c-with-facsuite-v1-1-1-windows.
“BD FACSLyric 3L 10C with FACSuite v1.1.1: Windows 10 Not Approved for Clinical Use.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69193-bd-facslyric-3l-10c-with-facsuite-v1-1-1-windows. Based on FDA recall #Z-0792-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0792-2019%22&limit=1).
The FDA announced on 2019-01-02 that Becton, Dickinson and Company, BD Biosciences is recalling three BD FACSLyric 3L 10C flow cytometers with FACSuite Clinical Software v1.1.1 because they were installed on Windows 10 workstations not cleared for clinical use. According to the FDA, this configuration violates regulatory requirements as Windows 10 is released for research use only.
How to tell if you have it
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1
Catalog number 662878
UPC 00382903389605
UPC 00382906628787
The hazard
The recalled devices were identified at a customer site in Maryland with FACSuite clinical v1.1.1 installed on a computer workstation running the Windows 10 operating system. The FDA states that Windows 10 OS is not a released configuration for clinical use and is released for research use only.
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 Trucount Tubes Recall (2022-10-03). Other recent recalls of similar products include Focalyx Fusion Software May Cause Patient Harm with Windows 10 (2025-12-23).
How to tell if you have this one
Check for the catalog number 662878 and serial numbers Z662878000056, Z662878000029, or R662382000007 on the device or its documentation. The software version v1.1.1 installed on Windows 10 is the specific issue.
Brand
BD Biosciences
Product
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify if your BD FACSLyric 3L 10C has FACSuite Clinical Software v1.1.1 installed on Windows 10.
Contact Manufacturer
Reach out to BD Biosciences for guidance on whether your unit is affected and next steps.
Where it went and when
Where it was distributed
Distributed in Maryland.
Listed by the agency
Not listed
FDA distribution: “US Distribution in MD.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Maryland.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0792-2019 (January 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0792-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.