Device recall
Z-1734-2009: CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or…
FDA device recall · Class II · Veridex, LLC
Key facts
| Recall number (Z-number) | Z-1734-2009 |
|---|---|
| Recall event | 52079 |
| Product | CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by Veridex, 33 Technology Drive, Warren, NJ 07059. Manufactured by Immunicon, Huntingdon Valley, PA. Immunicon was acquired by Veridex in August of 2008. |
| Product code | GKH |
| Recalling firm | Veridex, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2010 |
| 510(k) numbers | K040077 |
| FEI number | 3004619490 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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