Drug recall
BIOPHEN LMWH Control C4, REF 224201
FDA recall event 82468 · Class III · Aniara Diagnostica LLC
Key facts
| Event ID | 82468 |
|---|---|
| Recall numbers | Z-1188-2019, Z-1189-2019, Z-1190-2019 |
| Recalling firm | Aniara Diagnostica LLC |
| Product type | Devices |
| Products | BIOPHEN LMWH Control C4, REF 224201, BIOPHEN UFH Control C1, REF 224101, BIOPHEN UFH Control C2, REF 223901 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. |
| Initiation date | Mar 19, 2019 |
| Report date | Apr 24, 2019 |
| Termination date | Jul 12, 2019 |
| City | West Chester |
| State | OH |
| Country | United States |
| FEI number | 3005017664 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: