Device recall
Z-2090-2008: COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in…
FDA device recall · Class II · Siemens Medical Solutions Diagnostics
Key facts
| Recall number (Z-number) | Z-2090-2008 |
|---|---|
| Recall event | 48436 |
| Product | COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in monitoring patients for disease progress or response to therapy. |
| Product code | LTJ |
| Recalling firm | Siemens Medical Solutions Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 10, 2012 |
| PMA numbers | P930027 |
| FEI number | 3005250747 |
At a glance
- None 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