Device recall
Z-0632-05: DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or…
FDA device recall · Class II · Diasorin Inc.
Key facts
| Recall number (Z-number) | Z-0632-05 |
|---|---|
| Recall event | 30919 |
| Product | DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwestern Avenue, Stillwater, MN 55082-0285 |
| Product code | MID |
| Recalling firm | Diasorin Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2006 |
| 510(k) numbers | K001981 |
| FEI number | 2182595 |
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