Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0792-2019 — 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

U.S. FDA — Device Enforcement · United States · 2019-01-02 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0792-2019
Date of alert: 2019-01-02
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Becton, Dickinson and Company, BD Biosciences
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00382906628787

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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