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Vitek 2 AST-N447 Test Kit
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MEDICAL DEVICE RECALLMODERATE

Vitek 2 AST-N447 Test Kit

Biomerieux is recalling Vitek 2 AST-N447 Test Kits due to potential for false resistant results caused by pouch foil fractures.

What to do

Stop using the affected test kits and contact the manufacturer for further instructions.

Recalled
Listed
Updated
Recall No.
Z-2715-2026
Agency
FDA
Firm
Biomerieux Inc
Recall ID
99213
Status
ONGOING

Recall at a glance

Quantity recalled
45,900 cards

Why it was recalled

Biomerieux is recalling Vitek 2 AST-N447 Test Kits due to potential for false resistant carbapenem and/or cephalosporin results. This issue occurs when kits from the affected lot have pouch foil fractures, which may lead to inaccurate diagnostic results.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

VITEK 2 AST-N447 TEST KIT Product reference 424620

Lot code
0853293604
UDI-DI
0853293604, 03573026634551

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-07-10 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification