FDA recall, , Moderate risk
Vitek 2 AST-N447 Test Kit
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Summary by Recall Canary from the FDA notice
What happened
Biomerieux Inc, of Hazelwood, Missouri, recalled the VITEK 2 AST-N447 TEST KIT, product reference 424620, because of the potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. The recall, involving 45,900 cards, began on June 4, 2026, and was added to the FDA's Enforcement Report on July 9, 2026. The product was distributed internationally to Belgium and the Netherlands.
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.
A UDI-DI is the device identifier printed with the barcode on the device label.
Vitek 2 AST-N447 Test Kit Product reference 424620
- UDI-DI
- 0853293604
- 03573026634551
Recall details
- Company began the recall
- Sold in
International distribution to the countries of Belgium and the Netherlands.
- Company
- Biomerieux IncHazelwood, Missouri
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99213
- Recall number
- Z-2715-2026
- Quantity recalled
- 45,900 cards
All recalls from Biomerieux Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
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
