Device recall
Z-0302-2017: ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US…
FDA device recall · Class II · TEM Systems Inc
Key facts
| Recall number (Z-number) | Z-0302-2017 |
|---|---|
| Recall event | 75265 |
| Product | ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta. |
| Product code | JPA |
| Recalling firm | TEM Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 5, 2017 |
| 510(k) numbers | K101533 |
| 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