Device recall
Z-1606-2008: Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451)…
FDA device recall · Class II · Siemens Healthcare Diagnostics Inc.
Key facts
| Recall number (Z-number) | Z-1606-2008 |
|---|---|
| Recall event | 47518 |
| Product | Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, Newark, DE 19714 |
| Product code | MTF |
| Recalling firm | Siemens Healthcare Diagnostics Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 15, 2008 |
| PMA numbers | P000021 |
| FEI number | 1000122204 |
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