Device recall
Z-0952-2009: EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained…
FDA device recall · Class II · Epocal
Key facts
| Recall number (Z-number) | Z-0952-2009 |
|---|---|
| Recall event | 50209 |
| Product | EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of whole blood samples in the laboratory or at the point of care in hospitals, nursing homes, or other clinical care institutions. The… |
| Product code | CEM |
| Recalling firm | Epocal |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 6, 2009 |
| 510(k) numbers | K061597 |
| FEI number | 3004959793 |
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