Biomerieux Inc: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Recall Summary Biomerieux Inc. is recalling VITEK 2 AST-N447 test kits (product reference 424620) used to test bacteria's resistance to certain antibiotics. Some kits from affected production lots have damaged foil pouches, which can cause the test to incorrectly report that bacteria are resistant to carbapenem and/or cephalosporin antibiotics when they may not be. This recall affects medical facilities that received these kits in Belgium and the Netherlands.
- Recalling firm
- Biomerieux Inc
- Product
- VITEK 2 AST-N447 TEST KIT Product reference 424620
- Reason
- Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-04
- Status
- Open, Classified
- Distribution
- International distribution to the countries of Belgium and the Netherlands.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/608ad2b7-a684-41b5-82da-5e5750e176c1