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

Recall Z-2166-2018 — The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK¿ 2 ANC identification card is a single-use disposable. A mi

U.S. FDA — Device Enforcement · France · 2018-03-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2166-2018
Date of alert
2018-03-23
Country / jurisdiction
France
Risk level
Class II
Risk type
recall
Brand
BioMerieux SA
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
2440318203
Reported risk: A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.