FDA Device recall Z-3231-2026
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811 by Biomerieux, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3231-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-24 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Biomerieux |
| Distribution | n/a |
Product
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.
Identifiers
| code_info | UDI-DI 03573026637712; Lot Number 1333393504 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Biomerieux
- VITEK 2 AST-N447 TEST KIT Product reference 424620
FDA Device · Class II · 2026-07-15 · Biomerieux - VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01…
FDA Device · Class II · 2026-02-11 · Biomerieux - VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n
FDA Device · Class II · 2025-10-08 · Biomerieux - VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984
FDA Device · Class I · 2024-05-01 · Biomerieux - MYLA comprises AST Filters in conjunction with VITEK MS
FDA Device · Class II · 2023-03-08 · Biomerieux
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3231-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.