Reported Sep 30, 2026 · Ongoing · Updated Oct 6, 2026
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
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-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
- Lot codes and dates
UDI-DI 03573026637712Lot Number 1333393504
- Amount recalled
- 97680 units
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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