Device recall
Z-1627-2011: CEA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP…
FDA device recall · Class II · BioCheck Inc
Key facts
| Recall number (Z-number) | Z-1627-2011 |
|---|---|
| Recall event | 57506 |
| Product | CEA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum. |
| Product code | DHX |
| Recalling firm | BioCheck Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 25, 2011 |
| FEI number | 3002564473 |
At a glance
- None Linked 510(k)s
- 10–99 Products in the same recall event
- 1–9 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