Device recall
Z-1090-2016: ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro…
FDA device recall · Class II · TEM Systems Inc
Key facts
| Recall number (Z-number) | Z-1090-2016 |
|---|---|
| Recall event | 73357 |
| Product | ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System. |
| Product code | GGN |
| Recalling firm | TEM Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2016 |
| 510(k) numbers | K083842 |
| FEI number | 3008366794 |
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