Device recall
Z-1372-2022: epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the…
FDA device recall · Class II · Siemens Healthcare Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-1372-2022 |
|---|---|
| Recall event | 90432 |
| Product | epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens SMN#/Model #: 10736515 |
| Product code | CHL |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K192240 |
| FEI number | 3002637618 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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