bioMerieux recalls VITEK 2 Gram-negative AST Test Kits with Colistin formulation cs02n that may produce false resistant results for certain bacteria, affecting accurate antibiotic testing.
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
bioMerieux is recalling VITEK 2 Gram-negative AST Test Kits containing Colistin formulation cs02n. These kits may give false resistant results for specific bacteria like Pseudomonas aeruginosa and Acinetobacter baumannii, which could lead to incorrect antibiotic treatment decisions.
The Colistin formulation cs02n in these test kits may produce false resistant results for certain multi-drug-resistant bacteria. This could lead to incorrect antibiotic treatment decisions if healthcare providers rely on the test results.
Healthcare professionals using these test kits for bacterial identification and antibiotic susceptibility testing are most at risk. The recall applies to specific kits sold in multiple countries.
Look for test kits labeled 'VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n'. The kits were sold in Australia, Thailand, Turkey, Iberia, Germany, Italy, France, Spain, Portugal, Russia, Netherlands, Israel, Poland, Taiwan, Japan, Pakistan, and India.
Verify if your kit has the Colistin formulation cs02n and the specific product codes listed in the recall notice.
No, the recall does not require immediate discontinuation. The hazard is a potential for false results, not an immediate safety risk.
The kits were sold in Australia, Thailand, Turkey, Iberia, Germany, Italy, France, Spain, Portugal, Russia, Netherlands, Israel, Poland, Taiwan, Japan, Pakistan, and India.
Check the kit label for the specific product codes listed in the recall notice, such as AST-N412, AST-N427, AST-N438, etc.
We’ve drafted a message you can send bioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-2671-2025 — bioMerieux bioMerieux Hello, I own a bioMerieux that is covered by recall Z-2671-2025 from bioMerieux. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
