FDA Device recall Z-0853-2023
VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982
- FDA Device
- Class II
- ongoing
- Published 2023-01-11
On 2023-01-11 the FDA classified a Class II recall of VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982 by Biomerieux, citing as the temperature and time out of range was exceeded, product performances cannot be guaranteed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0853-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-09 |
| Published | 2023-01-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomerieux |
| Distribution | US |
Product
VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982
Reason
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Identifiers
| code_info | UDI/DI 03573026565923, Batch Numbers: 6852245503 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0853-2023%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.