Device recall
Z-1737-2011: diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination…
FDA device recall · Class II · DiaDexus, Inc
Key facts
| Recall number (Z-number) | Z-1737-2011 |
|---|---|
| Recall event | 56639 |
| Product | diaDexus PLAC Test ELISA Kit, Enzyme Immunoassay for Quantitative Determination of Lp-PLA2 in human plasma or serum, part number 90123, manufactured by diaDexus Inc, South San Francisco. |
| Product code | NOE |
| Recalling firm | DiaDexus, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 21, 2011 |
| 510(k) numbers | K062234 |
| FEI number | 3003643666 |
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