Device recall
Z-0382-06: Roche Elecsys total PSA CalSet, catalog number 11731696322.
FDA device recall · Class III · Roche Diagnostics Corp.
Key facts
| Recall number (Z-number) | Z-0382-06 |
|---|---|
| Recall event | 34273 |
| Product | Roche Elecsys total PSA CalSet, catalog number 11731696322. |
| Product code | LTJ |
| Recalling firm | Roche Diagnostics Corp. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 26, 2006 |
| PMA numbers | P990056, P990056S001 |
| FEI number | 1823260 |
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