FDA Device recall Z-2715-2026
VITEK 2 AST-N447 TEST KIT Product reference 424620
- FDA Device
- Class II
- ongoing
- Published 2026-07-15
On 2026-07-15 the FDA classified a Class II recall of VITEK 2 AST-N447 TEST KIT Product reference 424620 by Biomerieux, citing potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2715-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-04 |
| Published | 2026-07-15 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Biomerieux |
| Distribution | n/a |
Product
VITEK 2 AST-N447 TEST KIT Product reference 424620
Reason
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Identifiers
| code_info | Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Biomerieux
- VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
FDA Device · Class II · 2026-09-30 · 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-2715-2026%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.