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

Recall Z-1602-2015 — Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.

U.S. FDA — Device Enforcement · United States · 2015-03-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1602-2015
Date of alert: 2015-03-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomerieux Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 287303120

Reported risk: The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258

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.

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