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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01049-1
Product Name/Description ADVIA Chemistry XPT Systems with software version 1.0.3. An in vitro diagnostic medical device (IVD)

Siemens Material Number (SMN): 10723034

ARTG Number: 175890
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 28/10/2015
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue Siemens Healthcare Diagnostics has identified multiple issues with the ADVIA Chemistry XPT systems with software version 1.0.3 that may affect the day to day behaviour and/or workflow of the system as follows:

Auto Start-Up Failing
Calibration Interval Resets when a Reagent Blank (RBL) is run
Control Definition screen assumes that the range is defined is 2 SD (Standard Deviation)
Laboratory Information System (LIS) communication / Laboratory Automation (LAS) issue
Printer Driver Resets
ISE Calibration Ranges are too conservative for Urine Sodium (Na)
Archiving and deletion may fail
Workstation services may restart

With the alerts generated by the instrument for the scenarios impacting samples, the operator will be aware that a sample may not have been processed and can take action. Calibration and control issues are detectable through normal laboratory monitoring practices.
Recall Action Recall for Product Correction
Recall Action Instructions All the issues above except (Issue: Workstation services may restart) are corrected in software version 1.1 which is now available for installation on affected systems. The temporary actions defined in the customer letter should be undertaken until the affected systems have been upgraded to software version 1.1. The remaining issue will be corrected in a future software version.

This issue has been corrected in software version 1.2.

This action has been closed out on 24/10/2018
Contact Information 1800 310 300 - Siemens Technical Support Centre