Device recall
Z-1971-2013: epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of…
FDA device recall · Class II · Epocal
Key facts
| Recall number (Z-number) | Z-1971-2013 |
|---|---|
| Recall event | 65126 |
| Product | epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit. |
| Product code | CGA |
| Recalling firm | Epocal |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 31, 2016 |
| 510(k) numbers | K090109, K093297 |
| 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