Device recall
Z-2034-2012: epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis…
FDA device recall · Class II · Epocal Inc
Key facts
| Recall number (Z-number) | Z-2034-2012 |
|---|---|
| Recall event | 61147 |
| Product | epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system |
| Product code | CGA |
| Recalling firm | Epocal Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 18, 2013 |
| 510(k) numbers | K090109 |
| 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