| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00720-1 |
| Product Name/Description |
ADVIA Centaur XPT System
Siemens Material Number: 10711433
All the ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979)
ARTG Number: 175890 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has identified issues with all the ADVIA Centaur XPT system software versions that may affect the results generated by the system as described below:
1. There is potential for discrepant QC and patient results. Stop running the system until it is serviced if the conditions occur. The probability of this failure occurring is extremely unlikely.
2. If the Daily Cleaning Procedure (DCP) fails to complete there is potential for discrepant QC and patient results. The probability of this failure occurring is unlikely but possible if bulk fluids are not filled prior to starting the DCP.
3. There is potential for delayed results noticeable to the user as either absence of results or an error posted for the sample. No erroneous results will be reported.
Siemens advises the overall risk to health is low. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is asking users to follow the detailed instructions in the customer letter.
This action has been closed out on 14/10/2020 |
| Contact Information |
1800 310 300 – Siemens Customer Care Centre |