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 FA
Check against the official notice below — it lists the full affected range.
Becton, Dickinson and Company has recalled three BD FACSLyric flow cytometer systems with FACSuite Clinical Software v1.1.1 that were installed on workstations running Windows 10 operating system. The systems were distributed in Maryland. Windows 10 is not an approved configuration for clinical use with this device—it is only cleared for research use.
The source document does not specify a remedy or next steps for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Quantity: 3 devices Lot/code info: UDI: (01)00382906628787(11)180508(21)Z662878000056 serial number: Z662878000056 Work Station SN 2UA80820ZZ UDI: (01)00382906628787(11)180301(21)Z662878000029 serial number: Z662878000029 Work Station SN 2UA80820ZW UDI: (01)00382903389605(11)180315(21)11662382000007 serial number: R662382000007 Work Station SN 2UA8082101
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.