BIOPHEN UFH Control Plasma — Class III medical device recall Z-1743-2022
Terminated recall by Aniara Diagnostica LLC, reported 2022-09-21, distributed in IL, MI. Incorrect product labeling was included in the package.
| Recall number | Z-1743-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aniara Diagnostica LLC, West Chester, OH, United States |
| Recall initiated | 2022-06-28 |
| Classified | 2022-09-15 |
| Reported by FDA | 2022-09-21 |
| Terminated | 2024-04-18 |
| Distributed | IL, MI |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 03663537008290 |
| Lot numbers | FA2035 |
Product
BIOPHEN UFH Control Plasma
Reason for recall
Incorrect product labeling was included in the package.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1743-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.