Home / Recalls / Becton, Dickinson and Company, BD Biosciences / Z-0792-2019

Z-0792-2019 Class III Terminated

Recalled by Becton, Dickinson and Company, BD Biosciences — San Jose, CA

FDA device recall Z-0792-2019 was initiated by Becton, Dickinson and Company, BD Biosciences on January 2, 2019 and is designated Class III. 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 relea… The recall status is terminated (terminated May 7, 2021). Affected quantity: 3 devices.

Recall Details

Product Type: Devices
Report Date: February 13, 2019
Initiation Date: January 2, 2019
Termination Date: May 7, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3 devices

Product Description

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.

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 Pattern

US Distribution in MD.

Code Information

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

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