Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01292-1
Product Name/Description	ADVIA Centaur and ADVIA Centaur XP HBsAg II Assay. An in vitro diagnostic medical device (IVD) ADVIA Centaur and ADVIA Centaur XP HBsAg II (HBsII) Assay Reference Number: 10492138 Kit Lot numbers: 93076013, 94615013, 95344013, 95801013, 96628013, 98117014, 98508014, 12536014 An in vitro diagnostic medical device (IVD)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	24/12/2012
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	There is an increased number of falsely elevated patient samples for HBsAgII resulting in the number of initial positives reactive rates exceeding the initial reactive specificity as listed in the Instructions for Use (IFU). The increased false reactive rate may cause a delay in reporting results because additional testing is required.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is providing work around instructions for users to implement.
Contact Information	1800 310 300 - Siemens Technical Support Centre