FDA Device recall Z-0789-2023
VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
- FDA Device
- Class II
- ongoing
- Published 2023-01-11
On 2023-01-11 the FDA classified a Class II recall of VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343 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-0789-2023 |
| 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 YST TEST KIT VTK2 20 CARDS, CATALOG 21343
Reason
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Identifiers
| code_info | UDI/DI 03573026131937, Batch Numbers: 2432261103 |
|---|
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-0789-2023%22
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