Device recall
Z-1914-2010: GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit)…
FDA device recall · Class II · Diasorin Inc.
Key facts
| Recall number (Z-number) | Z-1914-2010 |
|---|---|
| Recall event | 53698 |
| Product | GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit), DiaSorin, Stillwater, Minnesota 55082-0285. Indicated for the quantitative determination of plasma renin activity (PRA) by the radioimmunoassay of generated angiotension I. |
| Product code | CIB |
| Recalling firm | Diasorin Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2012 |
| FEI number | 2182595 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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