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

Recall Z-2397-2012 — BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated co

U.S. FDA — Device Enforcement · United States · 2012-06-29 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2397-2012
Date of alert: 2012-06-29
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: BD Biosciences, Systems & Reagents
Product category: device
Product type: Devices

Reported risk: Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.

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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