Device recall
Z-1004-2012: CellTracks Analyzer II. A semi-automated fluorescence microscope used to…
FDA device recall · Class II · Veridex, LLC
Key facts
| Recall number (Z-number) | Z-1004-2012 |
|---|---|
| Recall event | 60943 |
| Product | CellTracks Analyzer II. A semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed… |
| Product code | NQI |
| Recalling firm | Veridex, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 17, 2015 |
| 510(k) numbers | K050145, K060110 |
| FEI number | 3004619490 |
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