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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: SMN: 11222258, 11223813)

ARTG Number: 175890
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 8/02/2017
Responsible Entity Siemens Healthcare Pty Ltd
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