Medical Device Recall: VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Biomerieux Inc · July 24, 2026
Reason for Recall
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.
Distribution
International distribution to the countries of Austria, Germany, Luxembourg.
Quantity Affected
97680 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3231-2026
Status: ongoing
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