Device recall
Z-1093-2014: Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910…
FDA device recall · Class II · Dako North America Inc.
Key facts
| Recall number (Z-number) | Z-1093-2014 |
|---|---|
| Recall event | 67380 |
| Product | Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and… |
| Product code | NYQ |
| Recalling firm | Dako North America Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 4, 2014 |
| PMA numbers | P100024 |
| 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