Device recall
Z-0580-2008: ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog #…
FDA device recall · Class II · Siemens Medical Solutions Diagnostics
Key facts
| Recall number (Z-number) | Z-0580-2008 |
|---|---|
| Recall event | 44725 |
| Product | ADVIA Centaur TnI-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog # 02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, Siemens Medical Solutions Diagnostics, Tarrytown, NY 10591 |
| Product code | MMI |
| Recalling firm | Siemens Medical Solutions Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 28, 2012 |
| 510(k) numbers | K053020 |
| FEI number | 2432235 |
At a glance
- 1–9 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