Recall Z-3231-2026 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Biomerieux Inc
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
| Date | Sep 18, 2026 (initiated Jul 24, 2026) |
| Status | Open, Classified |
| 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 |
| Action | An URGENT FIELD SAFETY NOTICE notification letter was sent to customers beginning 7/24/26. Required actions Dispose of any remaining inventory VITEK 2 AST-N461 TEST KIT (Ref 424811, Lot 1333393504) that were manufactured with Poucher 8 with timestamps from 10:06:00 to 11:11:59, as identified by product labeling. Inspect each pouch in inventory and dispose of cards with "P8" and timestamps between 10:06:00 to 11:11:59 on the label. Alternatively, dispose of all cards from Lot 1333393504 remaining in inventory. In accordance with your facility s policies, you may consider performing a retrospe |
| Quantity | 97680 units |
| Distribution | International distribution to the countries of Austria, Germany, Luxembourg. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.