Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation Recalled by bioMerieux, Inc. Due to Potential for false resistant results for Colistin (cs02n)...

Date: June 26, 2025
Company: bioMerieux, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact bioMerieux, Inc. directly.

Affected Products

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

Quantity: 235269 cards

Why Was This Recalled?

Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards

Where Was This Sold?

International distribution in the countries of Albania, Armenia, Australia, Austria, Belgium, Bosnia, Bulgaria, China, Croatia, Cyprus, Czech Republic/Slovakia, France, Germany, Greece, Iberia, India, Israel, Italy, Japan, Lithuania, Macedonia, Malaysia/Brunei, Moldova, Netherlands, Pakistan, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Switzerland, Taiwan, Thailand, and Turkey.

About bioMerieux, Inc.

bioMerieux, Inc. has 53 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report