FDA Device recall Z-1189-2019
BIOPHEN UFH Control C1, REF 224101
- FDA Device
- Class III
- terminated
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class III recall of BIOPHEN UFH Control C1, REF 224101 by Aniara Diagnostica, citing the manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1189-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-03-19 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Aniara Diagnostica |
| Distribution | MI, PA |
Product
BIOPHEN UFH Control C1, REF 224101
Reason
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Identifiers
| code_info | Lots F1700314P2, F1700314P3, F1700314P4, F1801638P1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1189-2019%22
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