TemporaryFDAOngoing
Can cause harm that is usually temporary.
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Check the device or its packaging for
UDI-DI 03573026637712; Lot Number 1333393504
- Why
- 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.
- Distributed
- International distribution to the countries of Austria, Germany, Luxembourg.
- Company
- Biomerieux Inc
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3231-2026 · retrieved 18 September 2026
Read the official notice