Device recall
Z-1189-2019: BIOPHEN UFH Control C1, REF 224101
FDA device recall · Class III · Aniara Diagnostica LLC
Key facts
| Recall number (Z-number) | Z-1189-2019 |
|---|---|
| Recall event | 82468 |
| Product | BIOPHEN UFH Control C1, REF 224101 |
| Product code | GGN |
| Recalling firm | Aniara Diagnostica LLC |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 12, 2019 |
| 510(k) numbers | K051472 |
| FEI number | 3005017664 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database