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

Medical DevicesSource: FDA (device) · Date: 2026-07-15

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Biomerieux Inc
Product
VITEK 2 AST-N447 TEST KIT Product reference 424620
Reason / hazard
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Classification
Class II
Status
Ongoing
Distribution / sold at
International distribution to the countries of Belgium and the Netherlands.
Recall initiated
2026-06-04
Code info
Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
Product quantity
45,900 cards
Voluntary mandated
Voluntary: Firm initiated
City
Hazelwood
State
MO
Country
United States
Event id
99213
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