Device recall
Z-2099-2016: Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro…
FDA device recall · Class II · Dako North America Inc.
Key facts
| Recall number (Z-number) | Z-2099-2016 |
|---|---|
| Recall event | 74408 |
| Product | Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dualcolor chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome… |
| Product code | NYQ |
| Recalling firm | Dako North America Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 2, 2016 |
| FEI number | 2022180 |
At a glance
- None 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