Device recall
Z-0613-2016: Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of…
FDA device recall · Class II · Siemens Healthcare Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0613-2016 |
|---|---|
| Recall event | 72570 |
| Product | Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine NPhosphostransferase, E. C. No. 2.7 .3.2) in heparinized plasma Catalog Number: CCKMB SMN:10445068 |
| Product code | JHX |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2016 |
| 510(k) numbers | K051650 |
| FEI number | 3002637618 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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