medical MODERATE Updated 2026-07-15

Biomerieux Inc recalls VITEK 2 AST-N447 TEST KIT Product reference 424620

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Recalled Product

VITEK 2 AST-N447 TEST KIT Product reference 424620

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Hazard / Issue

Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.

Issued by

FDA

Distribution: International distribution to the countries of Belgium and the Netherlands.
Lot/Code Info: Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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