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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00874-1
Product Name/Description	Chemistry 1 Calibrator used on Dimension Vista Systems (Magnesium assay calibrator). An in vitro diagnostic medical device (IVD). Catalogue Number: KC110 Siemens Material Number: 10445169 Lot Number: 3GM081 ARTG number: 182222
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/08/2014
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control (QC) and patient samples following calibration of MG with the Dimension Vista CHEM 1 CAL lot 3GM081. Investigation by Siemens confirms that QC and patient samples show low recovery of MG by 0.25 mg/dL [0.10 mmol/L] across the assay range following calibration with 3GM081.
Recall Action	Recall for Product Correction
Recall Action Instructions	CHEM 1 CAL lot 3GM081 expired on 1 July 2014; however, Siemens is advising their customers to immediately calibrate MG with an alternate lot of CHEM 1 CAL if a calibration of MG with this lot of CHEM 1 CAL is still active. Siemens recommends that the content of this letter and review of previous testing should be discussed with your Medical Director. This action has been closed-out on 03/06/2016.
Contact Information	1800 310 300 - Siemens Technical Support Centre