| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00468-1 |
| Product Name/Description |
Aperio eSlide Manager with ImageScope, software versions 12.2.1, 12.2.2 and 12.3. An in vitro diagnostic medical device (IVD)
ARTG Number: 242392 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
It is possible to have incorrect label information displayed when viewing multiple Hamamatsu .ndpi (Brightfield) and .ndpis (Fluorescent) images with ImageScope software. Slides which do not use the .ndpi file format are not affected. The correct labelling information is presented in the patient's case in eSlide Manager.
This is an isolated issue that may only be experienced by customers who meet all of the following criteria:
- Use Aperio eSlide Manager Release 12.2.1 or newer including version 12.3
- Use Hamamatsu .ndpi (Brightfield) or .ndpis (Fluorescent) image format
- Open multiple images exceeding the local server cache memory
No patient injury or adverse events have been reported. However, there is a potential for a delay in diagnosis, failure to diagnose or an incorrect diagnosis. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Leica Biosystems is advising users to discontinue use of Hamamatsu .ndpi and ndpis image formats with ImageScope viewing software, until a software correction can be performed. Leica is recommending users review cases containing the affected image formats to ensure patient label information is correct. This action has been closed out on 14 June 2017. |
| Contact Information |
1800 625 286 - Leica Biosystems Technical Support |