BIOPHEN UFH Control C1 — Class III medical device recall Z-1189-2019
Terminated recall by Aniara Diagnostica LLC, reported 2019-04-24, distributed in MI, PA. The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device p
| Recall number | Z-1189-2019 |
|---|---|
| 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 | 2019-03-19 |
| Classified | 2019-04-17 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2019-07-12 |
| Distributed | MI, PA |
| Quantity | 41 units |
| Lot numbers | F1700314P2, F1700314P3, F1700314P4, F1801638P1 |
| Model numbers | 224101 |
Product
BIOPHEN UFH Control C1, REF 224101
Reason for recall
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
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-1189-2019. 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.