bioMerieux VITEK 2 Gram-negative Test Kits May Give False Resistant Results for Colistin
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.
Lower-risk recall
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/51960-biomerieux-vitek-2-gram-negative-test-kits-may-give-false.
Source Summary by GovInfoNow · govinfonow.com/recall/51960-biomerieux-vitek-2-gram-negative-test-kits-may-give-false · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2671-2025
Cite this page
“bioMerieux VITEK 2 Gram-negative Test Kits May Give False Resistant Results for Colistin.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51960-biomerieux-vitek-2-gram-negative-test-kits-may-give-false. Based on FDA recall #Z-2671-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2671-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
bioMerieux- Category
Medical device
What to do — step by step
Check Kit Labels
Verify if your kit has the Colistin formulation cs02n and the specific product codes listed in the recall notice.
How this recall unfolded
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these test kits immediately?
No, the recall does not require immediate discontinuation. The hazard is a potential for false results, not an immediate safety risk.
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Where this comes from
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.
- Official source: FDA Recall #Z-2671-2025 (June 26, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2671-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.