FDA Device recall Z-0840-2023
GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057
- FDA Device
- Class II
- ongoing
- Published 2023-01-11
On 2023-01-11 the FDA classified a Class II recall of GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057 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-0840-2023 |
| 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
GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057
Reason
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Identifiers
| code_info | UDI/DI 3573026387761, Batch Numbers: 1009334990 |
|---|
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-0840-2023%22
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