FDAFDA recall Z-3231-2026 · Sep 30, 2026
Biomerieux Inc: VITEK 2 AST-N461 TEST KIT recall
Recall found
Product
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Reason for recall
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI 03573026637712; Lot Number 1333393504
- Quantity
- 97680 units
- Distribution
- International distribution to the countries of Austria, Germany, Luxembourg.
- Recalling firm
- Biomerieux Inc, Hazelwood, MO
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-24
Source: openFDA enforcement record Z-3231-2026 · search recall number Z-3231-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.