Device recall
Z-2175-2010: CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD…
FDA device recall · Class II · Veridex, LLC
Key facts
| Recall number (Z-number) | Z-2175-2010 |
|---|---|
| Recall event | 55908 |
| Product | CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a Johnson & Johnson Company Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood. |
| Product code | GKH |
| Recalling firm | Veridex, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 8, 2014 |
| 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