Recall – IVD software version in use with unreleased operating system

Company: Becton, Dickinson and Company, BD Biosciences
Date of Enforcement Report: 2/1/2019
Class III:

PRODUCT

BD FACSLyric(TM) 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric(TM) 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.

Recall Number: Z-0792-2019

REASON

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.

RECALLING FIRM/MANUFACTURER

Medtronic, Inc. on 1/2/2019. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
3 devices

DISTRIBUTION

US Distribution in MD.

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