Device recall
Z-2285-2012: PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test…
FDA device recall · Class III · Phadia US Inc
Key facts
| Recall number (Z-number) | Z-2285-2012 |
|---|---|
| Recall event | 62572 |
| Product | PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies) |
| Product code | MID |
| Recalling firm | Phadia US Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 12, 2012 |
| 510(k) numbers | K020758 |
| FEI number | 3004973408 |
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