FDA Device recall Z-0243-2022
API 50 CH, Model 50300
- FDA Device
- Class II
- terminated
- Published 2021-11-24
On 2021-11-24 the FDA classified a Class II recall of API 50 CH, Model 50300 by Biomerieux, citing there is potential to provide an incorrect organism identification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0243-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-30 |
| Published | 2021-11-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomerieux |
| Distribution | NY, SD, WI |
Product
API 50 CH, Model 50300
Reason
There is potential to provide an incorrect organism identification.
Identifiers
| code_info | Model 50300, Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0243-2022%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.