Device recall
Z-1205-2009: PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the…
FDA device recall · Class II · DiaDexus, Inc
Key facts
| Recall number (Z-number) | Z-1205-2009 |
|---|---|
| Recall event | 51215 |
| Product | PLAC Test Calibrator Kit, Five-level liquid calibrator set for use with the diaDexus PLAC Test Reagent Kit, assembled in a kit box with an outer label, Catalog numbers 90108 and 10-0108, manufactured by diaDexus inc., South San Francisco, CA. Intended to establish points of reference that are used… |
| Product code | NOE |
| Recalling firm | DiaDexus, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 5, 2010 |
| 510(k) numbers | K072599 |
| 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