Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00318-1
Product Name/Description	ADVIA Chemistry Systems Liquid Specific Protein Calibrator (an in vitro diagnostic medical device (IVD)) Siemens Material Number (SMN): 10311929 Part Number: B03-4845-01 Lot Number: 244560 Expiration Date: 2014-05-28 ARTG Number: 185171
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	15/04/2013
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	The System Specific Values (SSVs) for the Rheumatoid Factor (RF) assay have been reassigned for this lot. Siemens has determined that the Rheumatoid Factor SSVs currently assigned to this lot may cause an average -15% shift in quality control and sample recovery.
Recall Action	Recall for Product Correction
Recall Action Instructions	Siemens is providing updated system specific values for the affected lot as a work around solution.
Contact Information	1800 310 300 - Siemens Technical Support Centre