Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00905-1
Product Name/Description ADVIA Centaur BR Assay for CA 27.29, ADVIA Centaur BR Assay for CA 15-3. An in vitro diagnostic devices (IVD)

ADVIA Centaur BR Assay for CA 27.29
Reference numbers: 03896216 and 02419937

ADVIA Centaur BR Assay for CA 15-3
Reference numbers: 01157807 and 03204829

Multiple lot numbers
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/09/2012
Responsible Entity Siemens Ltd
Reason/Issue An onboard stability issue is resulting in an out of specification calibration interval potentially giving rise to false positive results.
Recall Action Recall
Recall Action Instructions Siemens is providing work around instructions for users to follow. This action has been closed-out on 16/02/2017.
Contact Information 1800 310 300 - Siemens Technical Support Centre