Device recall
Z-0617-2016: Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used…
FDA device recall · Class II · Siemens Healthcare Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-0617-2016 |
|---|---|
| Recall event | 72570 |
| Product | Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061 |
| Product code | DHA |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2016 |
| 510(k) numbers | K060548 |
| 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