bioMérieux VITEK 2 AST-N461 Test Kit
The Vitek 2 AST-N461 test kit may cause false resistant results due to card pouch damage.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Biomerieux Inc of Hazelwood, Missouri began a recall of the Vitek 2 AST-N461 Test Kit, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811, on July 24, 2026. The issue is related to card pouch damage associated with a portion of the lot 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.
The product was distributed internationally to the countries of Austria, Germany, and Luxembourg. The recall was added to the FDA's Enforcement Report on September 18, 2026, and was in the FDA's weekly enforcement report on September 30, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Affected if its UDI-DI is listed.
Vitek 2 AST-N461 Test Kit, Gram Negative Susceptibility Testing - AUTOMATED, Reference Number 424811
- UDI-DI
- 03573026637712
- 1333393504
Details
- Company began the recall
- Sold in
International distribution to the countries of Austria, Germany, Luxembourg.
- Event ID
- 99749
- Recall No.
- Z-3231-2026
- Company
- Biomerieux IncHazelwood, Missouri
- Hazard
- Device defect
- Quantity recalled
- 97680 units
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
