Device recall
Z-1152-2014: HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC…
FDA device recall · Class II · Leica Biosystems Imaging, Inc.
Key facts
| Recall number (Z-number) | Z-1152-2014 |
|---|---|
| Recall event | 67418 |
| Product | HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ScanScope System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist… |
| Product code | NOT |
| Recalling firm | Leica Biosystems Imaging, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 15, 2014 |
| FEI number | 3006791373 |
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