| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00208-1 |
| Product Name/Description |
ADVIA Centaur XPT System with software versions V1.0 to V1.2. An in vitro diagnostic medical device (IVD).
Siemens Material Number: 10711433
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, 11219656)
V1.1 (Bundle 1.1.243 SMN 11221979, 11222064)
V1.2 (Bundle: 1.2.223.0 SMN: 11222258, 11223813)
ARTG Number: 175890 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
Multiple software issues have been identified for software versions V1.0 to V1.2. These issues may affect the operation and workflow of the ADVIA Centaur XPT system, and the potential exists for an apparent delay to testing. The issues are detailed in the customer letter and relate to the following: System Status Unknown, LAS Communication, QC Profiles, 'No Primary' Error, and LIS Specification. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The software issues will be corrected in future software versions. In the interim, Siemens is providing detailed work around instructions in the customer letter. It is recommended that the letter is reviewed with the laboratory Medical Director.
Update May 2018: Siemens have provided communication to customers that some of the issues identified have been corrected in V1.3. Siemens will contact sites to schedule a time to update systems if it has not already been updated.
The remaining issues will be corrected in future software versions.
This action has been closed out on 11/01/2021 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |