Official recall notice
Vitek 2 AST-N461 Test KIT Recall (Sep 2026) – Biomerieux
Product: VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
- Recall date
- 2026-09-30
- Brand
- Biomerieux Inc
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Product description
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.
Affected products
UDI-DI 03573026637712; Lot Number 1333393504