Reported Feb 13, 2019 · Terminated
BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance…
Becton, Dickinson and Company, BD Biosciences
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton, Dickinson and Company, BD Biosciences · 2350 Qume Dr · San Jose, CA · 95131-1812
Is this the product you have?
- 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 loaded onto an adjacent PC workstation and is used to operate the instrument, acquire samples, and analyze data. Quality control performance, tracking, and reporting are streamlined and automated. Routine tasks such as daily cleaning and shutdown can be programmed to occur automatically. The BD FACSuite clinical software allows users to run BD IVD assays.
- Lot codes and dates
- UDI(01)00382906628787(11)180508(21)Z662878000056
- serial numberZ662878000056
- Work Station SN 2UA80820ZZ UDI(01)00382906628787(11)180301(21)Z662878000029
- serial numberZ662878000029
- Work Station SN 2UA80820ZW UDI(01)00382903389605(11)180315(21)11662382000007
- serial numberR662382000007 Work Station SN 2UA8082101
- Amount recalled
- 3 devices
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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