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

Recall Z-0618-2019 — VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2

U.S. FDA — Device Enforcement · United States · 2018-10-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0618-2019
Date of alert: 2018-10-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: bioMerieux, Inc.
Product category: device
Product type: Devices

Reported risk: False resistant results for Streptococcus anginosus and Streptococcus constellatus strains were reported.

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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