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

Recall Z-1640-2016 — Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Entero

U.S. FDA — Device Enforcement · United States · 2016-02-24 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1640-2016
Date of alert: 2016-02-24
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Biomerieux Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 739348620

Reported risk: Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.

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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