| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01256-1 |
| Product Name/Description |
cobas Product System Manager (PSM) (Analyser software), all versions. An in vitro diagnostic medical device (IVD).
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
PSM can be configured to block the validation of patient results in the event of a QC failure. This mechanism may not function as expected if the analyser system time is ahead of the PSM system time by more than 2 minutes. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
As an interim measure, the sponsor is providing work around instructions to reduce the probability of occurrence. A software update will be installed to permanently correct the issue as soon as possible. |
| Contact Information |
02 9860 2252 - Roche Diagnostics |