# FDA recall Z-2671-2025

> **bioMerieux, Inc.** · Class II · device recall initiated 2025-06-26.

## Product

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

## 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

## Distribution

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.

## Key facts

- **Recall number:** Z-2671-2025
- **Recalling firm:** bioMerieux, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-26
- **Report date:** 2025-10-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2671-2025

## Citation

> AI Analytics. FDA recall Z-2671-2025. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-2671-2025. Source: US FDA. Licensed CC0.

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