| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00278-1 |
| Product Name/Description |
cobas 4800 - z 480 (Real time PCR sample preparation, amplification and detection instrument). An in vitro diagnostic medical device (IVD).
All serial numbers affected |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
Roche has advised that in rare instanced channel shifted results have been generated with cobas 4800 assays run on v1.x software of the cobas 4800 system. Raw data review indicates that in these cases, all signals are shifted by one channel:
- Channel 1 results report as channel 2
- Channel 2 results report as channel 3
- Channel 3 results report as channel 4
- Channel 4 results report as channel 1.
In the reported cases the results of the runs were either invalid or the preponderance of individual patient specimen showed to be invalid. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche is providing end users with work around instructions to mitigate the issue. A software update to detect and mitigate the issue will be implemented in late 2013. This action has been closed-out on 28/01/2016 |
| Contact Information |
1800 645 619 - Roche National Support Centre |