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Biomerieux Inc: VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811

Medical DevicesSource: FDA (device) · Date: 2026-09-30

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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-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Reason / hazard
The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.
Classification
Class II
Status
Ongoing
Distribution / sold at
International distribution to the countries of Austria, Germany, Luxembourg.
Recall initiated
2026-07-24
Code info
UDI-DI 03573026637712; Lot Number 1333393504
Product quantity
97680 units
Voluntary mandated
Voluntary: Firm initiated
City
Hazelwood
State
MO
Country
United States
Event id
99749
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