| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01232-1 |
| Product Name/Description |
MagNA Pure 96. An in vitro diagnostic medical device (IVD)
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
Due to a software malfunction, the MagNA Pure 96 system may not refill the internal system fluid reservoir before and during the load check at the beginning of a run. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche is providing work around instructions for users to implement. |
| Contact Information |
1800 645 619 - Roche National Support Centre |