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.
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.
Windows 10 is not approved for clinical use by regulatory bodies and is only intended for research. Using it with BD FACSuite Clinical Software could cause inaccurate test results or system instability in medical settings.
Healthcare facilities using BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1 installed on Windows 10. Laboratory staff and medical professionals are most at risk due to potential testing errors.
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.
Verify if your BD FACSLyric 3L 10C has FACSuite Clinical Software v1.1.1 installed on Windows 10.
Reach out to BD Biosciences for guidance on whether your unit is affected and next steps.
Windows 10 is only approved for research use, not clinical settings, which could lead to inaccurate test results or system instability.
Check for the catalog number 662878 and specific serial numbers listed in the recall notice.
The recall record does not specify a remedy; affected users should contact BD Biosciences for guidance.
We’ve drafted a message you can send BD Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0792-2019 — BD Biosciences BD Biosciences Hello, I own a BD Biosciences that is covered by recall Z-0792-2019 from BD Biosciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
