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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00816-3
Product Name/Description Calibrator B from ADVIA Centaur Prolactin Assay (used with ADVIA Centaur CP 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 has confirmed analytical sensitivity of greater than the 0.3ng/mL described in the Instructions For Use with multiple ADVIA Centaur Prolactin reagent lots and multiple Calibrator B lots when run on the ADVIA Centaur Cp only.
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