Lower riskMedical device recall · FDA · Published January 26, 2018
bioMerieux VITEK 2 Gram Positive Test Kits May Miss MRSA Detection
bioMerieux recalls VITEK 2 Gram Positive Cefoxitin and Oxacillin test kits due to increased non-detected MRSA cases. Affected kits have specific UDI numbers and are used in lab testing.
Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
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📍Recalling firmbioMerieux, Inc.100 Rodolphe St · Durham, NC 27712-9402
✎ GovInfoNow plain-language explainer
bioMerieux is recalling certain VITEK 2 Gram Positive test kits because lab reports show more MRSA bacteria going undetected. This matters because MRSA is a dangerous infection that can cause serious health issues if not treated properly. Read more at govinfonow.com/recall/72091-biomerieux-vitek-2-gram-positive-test-kits-may-miss-mrsa.
“bioMerieux VITEK 2 Gram Positive Test Kits May Miss MRSA Detection.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72091-biomerieux-vitek-2-gram-positive-test-kits-may-miss-mrsa. Based on FDA recall #Z-2817-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2817-2018%22&limit=1).
The FDA announced on Jan. 26, 2018, that bioMerieux, Inc. is recalling VITEK 2 Gram Positive AST products due to an increased rate of non-detected MRSA. The agency classified the recall as Class I.
Customer reports indicated an increase in the rate of non-detected MRSA associated with the VITEK 2 AST-P631 product. The recall involves components for an automated in vitro diagnostic system designed for bacterial identification and antimicrobial susceptibility testing.
Context
GovInfoNow's records show Biomerieux Inc has issued 36 other recalls since July 12, 2017. Recent brand recalls include the VITEK 2 AST-N461 Test Kit recall on July 24, 2026, and the VITEK 2 AST-N447 Kit recall on June 4, 2026. Other recent recalls of similar products include the BioFire Joint Infection Panel Recall (April 22, 2026) and the Meridian Bioscience Revogene C. difficile Test Recall (Dec. 5, 2025).
How to tell if you have this one
Check for UDI numbers starting with 03573026426804, 03573026242060, 03573026355173, 03573026437183, or 03573026553982 on the test kits. These are specific to the VITEK 2 AST-P631, AST-GP67, AST-GP71, AST-GP75, and AST-GP78 kits.
Brand
bioMerieux
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check UDI Numbers
Look for specific UDI numbers on the test kits to confirm if they are affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution. US nationwide including Puerto Rico, Bermuda, Brazil, Canada, China, Curacao, Costa Rica, Dominican Republic, Ecuador, France, Guatemala, Indonesia, Israel, Hong Kong, South Korea, South Africa, Mexico, Myanmar,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2817-2018 (January 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2817-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 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.