Reported Jul 15, 2026 · Ongoing

VITEK 2 AST-N447 TEST KIT Product reference 424620

Biomerieux Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biomerieux Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320

Is this the product you have?

  • VITEK 2 AST-N447 TEST KIT Product reference 424620
Lot codes and dates
  • Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
Amount recalled
45,900 cards

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.