| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00905-1 |
| Product Name/Description |
ADVIA Centaur BR Assay for CA 27.29, ADVIA Centaur BR Assay for CA 15-3. An in vitro diagnostic devices (IVD)
ADVIA Centaur BR Assay for CA 27.29
Reference numbers: 03896216 and 02419937
ADVIA Centaur BR Assay for CA 15-3
Reference numbers: 01157807 and 03204829
Multiple lot numbers |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
An onboard stability issue is resulting in an out of specification calibration interval potentially giving rise to false positive results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is providing work around instructions for users to follow. This action has been closed-out on 16/02/2017. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |