Device recall
Z-1540-2012: Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1540-2012 |
|---|---|
| Recall event | 61629 |
| Product | Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge Product Usage: The TPSA method is an in vitro diagnostic test for the quantitative measurement of total prostate specific antigen (PSA) in human serum and plasma on the Dimension Vista(R) System |
| Product code | MTF |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 2, 2013 |
| PMA numbers | P000021, P000021S013 |
| FEI number | 2517506 |
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