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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00815-3
Product Name/Description Calibrator B from ADVIA Centaur FSH Assay (used with ADVIA Centaur or ADVIA Centaur XP System). An in vitro diagnostic medical device (IVD)

Multiple Ref / Lot numbers & Expiration dates
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 10/08/2012
Responsible Entity Siemens Ltd Diagnostics Division
Reason/Issue Siemens confirmed analytical sensitivity values greater than 0.3mlU/mL described in the Instructions For Use when evaluating multiple lots of the ADVIA Centaur FSH assay and Calibrator B on the ADVIA Centaur and ADVIA Centaur XP system.
Recall Action Recall for Product Correction
Recall Action Instructions Siemens is providing work around instructions for users to follow.
Contact Information 1800 310 300 - Siemens Technical Support Centre