United StatesVITEK 2 AST-N447 TEST KIT (product reference 424620, lot 0853293604, UDI‑DI 03573026634551) distributed to Belgium and the Netherlands is being recalled; 45,900 cards are affected. Kits with pouch foil fractures may give false resistant carbapenem and/or cephalosporin results. The product is distributed outside the U.S. (not registered in the U.S.).
What's being recalled
VITEK 2 AST-N447 TEST KIT Product reference 424620
Recalling firm: Biomerieux Inc, Hazelwood, MO, United States.
How to identify it
Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
The hazard
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
International distribution to the countries of Belgium and the Netherlands.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)