Device recall
Z-2207-2015: ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc
Key facts
| Recall number (Z-number) | Z-2207-2015 |
|---|---|
| Recall event | 71337 |
| Product | ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA… |
| Product code | MMI |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 17, 2019 |
| 510(k) numbers | K053020 |
| FEI number | 1219913 |
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