Device recall
Z-0429-2011: diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus, Inc…
FDA device recall · Class II · DiaDexus, Inc
Key facts
| Recall number (Z-number) | Z-0429-2011 |
|---|---|
| Recall event | 56017 |
| Product | diaDexus PLAC Test ELISA Kit; Manufactured and distributed by diaDexus , Inc., South San Francisco, CA; Model Part Number: 90123 The diaDexusPLAC Test ELISA Kit is an enzyme Immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma and serum… |
| Product code | NOE |
| Recalling firm | DiaDexus, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 11, 2011 |
| FEI number | 3003643666 |
At a glance
- None 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