Device recall
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
- Recall number
- Z-3231-2026
- Event id
- 99749
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Biomerieux Inc
- Report date
- Sep 30, 2026
- Posted
- Sep 18, 2026
- Initiated
- Jul 24, 2026
- Center classification date
- Sep 18, 2026
- Product code
- LON
- Device type
- System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- 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.
- Root cause
- Packaging process control
- Quantity
- 97680 units
- Code info
- UDI-DI 03573026637712; Lot Number 1333393504
- Distribution
- International distribution to the countries of Austria, Germany, Luxembourg.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Hazelwood, MO, United States