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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00062-1
Product Name/Description	ADVIA Chemistry Systems Drug Calibrator I for Phenytoin 2 and Phenobarbital 2 Assays. An in vitro Diagnostic Medical Device. Lot Number: 3JD018 Expiration Date: April 2015 Siemens Material Number: 10376770 ARTG Number: 175699
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	28/01/2015
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	Siemens Healthcare Diagnostics has determined that incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for the ADVIA Chemistry Systems Phenytoin 2 (PHNY_2) and Phenobarbital 2 (PHNB_2) assays. This issue was determined to be the result of calibrator value miscalculation. Calibrator lot 3JD018 has now been value assigned to align with the correct calibrator values. This poses a risk of an incorrect value of -10% being assigned for Phenytoin testing and 3% for Phenobarbital. Siemens considers these differences are negligible and would not be considered substantially relevant to impact clinical care in practice.
Recall Action	Recall for Product Correction
Recall Action Instructions	Calibrator value reassignments are being provided in the Customer Letter for users to correct the problem. This action has been closed-out on 14/02/2017.
Contact Information	1800 310 300 - Siemens Technical Support Center