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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00441-1
Product Name/Description ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP

ADVIA Centaur Systems TSH3 Ultra 100T, 500T
Catalogue No: 06491072 & 06491080
Kit Lots Ending In: 266, 267, 269, 270, 271, 272 & 273

ADVIA Centaur Systems VitD 100T, 500T
Catalogue No: 10491994, 10699201, 10631021 & 10699533
Kit Lots Ending In: 023, 024, 025, 026, 027, 050, 051, 052, 053 & 054

ADVIA Centaur BRAHMS PCT 100T
Catalogue No: 10378883
Kit Lots Ending In: 020, 021, 022, 023 & 024

ARTG No: 175698 & 175700
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 17/04/2014
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue Siemens Healthcare has confirmed that samples containing fluorescein (dye commonly used in fluroescein angiography) may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is notifying their customers of the potential for samples with fluorescein to show interference and the Instructions for Use are currently being updated.
Contact Information 1800 310 300 - Siemens Technical Support Centre