Recall Z-3231-2026— Biomerieux Inc
Class II · Ongoing
Class II FDA medical device recall by Biomerieux Inc, initiated 2026-07-24. FDA's recall record names no specific 510(k) clearance for this event. Product: VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811. Reason: 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..
- Recalling firm
- Biomerieux Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-24
- Firm location
- Hazelwood, MO, United States
Product description
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.