| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01032-1 |
| Product Name/Description |
BenchMark ULTRA with software versions VSS 11.9 or higher, and DISCOVERY ULTRA clinical chemistry analysers (used for detecting and preparing tissue morphology and components). An in vitro diagnostic medical device (IVD).
BenchMark ULTRA instrument
Material Number: 05342716001
Software versions VSS 11.9 or higher
DISCOVERY ULTRA instrument
Material Number: 05987750001
ARTG number: 173917 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
Internal investigations by Roche Diagnostics have uncovered the potential for incorrect slide staining (IHC/ISH) to occur on the BenchMark ULTRA instrument or DISCOVERY ULTRA instrument running Ventana System Software (VSS) 11.9 or higher, due to the possibility of a duplicate keycode error.
The embedded software for the barcode reader has an identified issue, which on presentation of this error may result in two slides erroneously receiving the same stain protocol regardless of what should have been indicated in the software for that keycode. The barcode reader fails to purge previously read barcode information and applies the same protocol details to a subsequent slide. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche is advising users to use same-slide controls as per the package insert and review run reports at the end of each run to ensure the intended staining protocol was used on each slide. Additionally, ensure each host has an adequate keycode range allocated. Roche will be performing a software upgrade as a permanent correction. This action has been closed-out on 26/08/2016. |
| Contact Information |
02 9860 2357 Regulatory Affairs and Quality Manager |