| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01139-1 |
| Product Name/Description |
ADVIA Centaur and Centaur XP Instrument Systems (immuno-assay analysers). An in vitro diagnostic medical device (IVD)
Catalogue numbers: 078-A001-xx and 078-A011-03 (respectively) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/11/2012 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed occurrences of the system either:
- Failing to detect that the Wash 1 bottle and reservoir is empty, or
- Incorrectly indicating that the Wash 1 bottle and reservoir is empty when it is actually full.
If the system fails to detect an empty Wash 1 bottle and reservoir, it can continue to process samples and product erroneous but believable results which are falsely high or low (depending if the assay architecture is direct or indirect). This issue potentially affects only those assays that use Wash 1. |
| 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 Customer Care Centre |