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

Recall Z-2671-2025 — VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only

U.S. FDA — Device Enforcement · United States · 2025-06-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2671-2025
Date of alert
2025-06-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
bioMerieux, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0143139204
Reported risk: Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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