| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00573-1 |
| Product Name/Description |
ADVIA Centaur XPT Systems. An in vitro diagnostic medical device (IVD)
Siemens Material Number (SMN): 10711433
ARTG Number: 175890 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has identified an issue with the ADVIA Centaur XPT default setting for the Daily Maintenance Task (or Daily Cleaning Procedure) frequency. Instruments may have the Daily Maintenance Task frequency set to “As needed” instead of “Daily”. Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users to not release results generated by the system if quality control results are not within acceptable ranges, and is providing instructions for users to check the daily maintenance tasks. If the frequency is set to "As Needed", users should contact Siemens in order for the frequency to be changed. All systems will be checked during the next scheduled maintenance. Siemens is not recommending a review of previously generated results. However, a review of previously generated results is at the discretion of the Laboratory Director.
This action has been closed out on the 14/09/2018 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |