bioMerieux, Inc.: Device Recall

Recall #Z-2671-2025 · 06/26/2025

Class II: Risk

Recall Details

Recall Number: Z-2671-2025
Classification: Class II
Product Type: Device
Recalling Firm: bioMerieux, Inc.
Status: Ongoing
Date Initiated: 06/26/2025
Location: Durham, NC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 235269 cards

Reason for Recall

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

Product Description

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

Distribution Pattern

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.

Other Recalls by bioMerieux, Inc.

Class II: Risk 01/05/2026

Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.

View all recalls by bioMerieux, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.