Biomerieux Inc recalls VITEK 2 AST-N461 TEST KIT
- Recalling company
- Biomerieux Inc
- Product
- VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
- Reason
- The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 24, 2026
- Reported
- Sep 30, 2026
- Distribution
- International distribution to the countries of Austria, Germany, Luxembourg.
- Status
- Ongoing
- Quantity
- 97680 units
- Lot / codes
- UDI-DI 03573026637712; Lot Number 1333393504
- Company location
- Hazelwood, MO
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3231-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3231-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.