| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01205-1 |
| Product Name/Description |
ADVIA Centaur XPT System, with software versions V1.0.1, V1.0.2 and V1.0.3
Siemens Material Number (SMN): 10711433
Software version 1.0.1
Bundle: 1.0.912
SMN: 10819704
Software version 1.0.2
Bundle: 1.0.1086
SMN: 11219806
Software version 1.0.3
Bundle: 1.0.1108
SMN: 11220781
ARTG Number: 175890 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has identified a number of issues that may affect the operation and workflow of the system.
A summary of the issues is listed below. However this is not a comprehensive list. Please refer to the customer letter for the full details.
- If the assay is being run with multiple replicates defines, the analyser reports the results as a mean for all replicate results. This may lead to incorrect diagnosis. If the final result rule is disabled, it may lead to delayed diagnosis of Hepatitis C viral infection or HIV. If the manual final result rule is being used with multiple replicates, it may lead to a missed diagnosis of Toxoplasmosis. If you are running samples with Replicates set to any value greater than 1, Siemens recommends a look back of all results that may be affected.
- If there is a unit change in Test Definition for assay & the Delta check functionality is enabled, it may lead to incorrect flagging. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users that a number the issues may be corrected with software upgrade V1.1. The remaining issues will be corrected in a future software update, and Siemens is providing work around instructions as a interim measure.
Siemens is recommends a lookback of patient results if users are running samples with replicates greater than 1 and discussing the customer letter with the Laboratory Director.
This action has been closed out on 25/10/2018 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |