Device recall
Z-2399-2008: PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric…
FDA device recall · Class II · DiaDexus, Inc
Key facts
| Recall number (Z-number) | Z-2399-2008 |
|---|---|
| Recall event | 49044 |
| Product | PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box. |
| 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