| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01113-1 |
| Product Name/Description |
Cobas 8000 Patient sample and control recovery on Cobas c 701/702 modules (clinical chemistry analyser). An in vitro diagnostic medical device (IVD)
Multiple affected assays |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
A software bug has been detected on the Cobas 8000, Cobas c 701/702 modules, which under certain conditions can lead to a mismatch between reagent probe positioning during pipetting and the aspirate sample volumes, leading to possible incorrect results. Until the new software version is available, Roche have updated the application e-barcodes for the affected assays, which reduce the number of available tests. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche will be providing work around instructions to mitigate the risk and will be providing a software update to permanently correct the issue. |
| Contact Information |
1800 645 619 - Roche National Support Centre |