FDA Device recall Z-1743-2022
BIOPHEN UFH Control Plasma
- FDA Device
- Class III
- terminated
- Published 2022-09-21
On 2022-09-21 the FDA classified a Class III recall of BIOPHEN UFH Control Plasma by Aniara Diagnostica, citing incorrect product labeling was included in the package.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1743-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-06-28 |
| Published | 2022-09-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aniara Diagnostica |
| Distribution | IL, MI |
Product
BIOPHEN UFH Control Plasma
Reason
Incorrect product labeling was included in the package.
Identifiers
| code_info | UDI-DI (GTIN): 03663537008290 Reference No.: 223101; Lot Code: FA2035 |
|---|
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-1743-2022%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.