VITEK 2 AST-N461 TEST KIT recall (Biomerieux Inc)
Medical deviceClass IIOngoing
Summary: Biomerieux Inc is recalling 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.
What is being recalled
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
International distribution to the countries of Austria, Germany, Luxembourg.
How to tell if yours is affected
UDI-DI 03573026637712; Lot Number 1333393504
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3231-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 24, 2026 |
| Reported | September 30, 2026 |
| Company | Biomerieux Inc |
| Company location | Hazelwood, MO, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 97680 units |
More recalls from Biomerieux Inc · all medical device recalls · recalls from July 2026