| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00799-3 |
| Product Name/Description |
ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) reagent kit. An in vitro diagnostic medical device (IVD)
HIV 1/O/2 (EHIV) Readypack Lot Number Ending In: 093, 095, 097, 101, 103, 105, 107, 109
Multiple Kit Lots |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
There have been reports concerning quality control results outside of the expected ranges. Siemens has determined that this issue is due to a decrease in the onboard stability of the EHV assay reagents. This issue will be identified by the quality control material. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing work around instructions for users to follow. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |