Device recall
Z-2400-2008: PLAC Test ELISA kit, catalog number 90106, enzyme immunoassay for the…
FDA device recall · Class II · DiaDexus, Inc
Key facts
| Recall number (Z-number) | Z-2400-2008 |
|---|---|
| Recall event | 49044 |
| Product | PLAC Test ELISA kit, catalog number 90106, enzyme immunoassay for the quantitative determination of Lp-PLA2 in human plasma and serum, kit containing coated microwell stripplate and reagents (12 strips, 1 set calibrators 1 to 6, 0.25 ml each, 20x wash buffer, 50 mL, conjugate 23 mL, TMB, 11 mL, Stop… |
| Product code | NOE |
| Recalling firm | DiaDexus, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 22, 2009 |
| 510(k) numbers | K030477 |
| 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