Vitek 2 Ast-n447 Test KIT Product recall
VITEK 2 AST-N447 TEST KIT Product reference 424620
Why was Vitek 2 Ast-n447 Test KIT Product recalled?
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
- Product
- VITEK 2 AST-N447 TEST KIT Product reference 424620
- Recalling firm
- Biomerieux Inc
- Quantity
- 45,900 cards
- Distribution
- International distribution to the countries of Belgium and the Netherlands.
- Recall date
- July 15, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)