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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01060-1
Product Name/Description	Calibrator E used for calibration of the ADVIA Centaur Systems Cortisol, Progesterone and Testosterone assays Catalogue Number: 04634452 Siemens Material Number: 10309079 Multiple kit lot numbers affected ARTG Number: 175698
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	7/10/2014
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	Siemens Healthcare Diagnostics has identified a positive bias for Calibrator E kit lots ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves. Patient serum samples evaluated with the ADVIA Centaur Cortisol assay and calibrated with affected lots of Calibrator E kit demonstrate an average positive bias of 16% across the assay range with a maximum bias of 28%. Patient serum samples evaluated with the ADVIA Centaur Systems Progesterone assay and calibrated with affected lots of Calibrator E kit demonstrate a positive bias with samples above 30 ng/mL. The average positive bias on the ADVIA Centaur/ADVIA Centaur XP is 20% with a maximum bias of 39%. The average positive bias on the ADVIA Centaur CP is 17% with a maximum bias of 35%. The ADVIA Centaur Systems Testosterone assay is not affected by this correction.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is notifying their customers of the potential for positive bias when using the affected calibrators. As the bias only occurs outside of the useful clinical range the calibrators can continue to be used. Unaffected calibrators can be ordered if required. This action has been closed-out on 01/03/2016.
Contact Information	1800 310 300 - Siemens Technical Support Center