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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01073-1
Product Name/Description	Elecsys Thyroglobulin assay used with the Elecsys Modular Analytics analysers An in vitro diagnostic medical device (IVD) Material Number: 05118921-190 Lot Number: 16934601
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	22/10/2012
Responsible Entity	Roche Diagnostics Australia Pty Limited
Reason/Issue	Roche have confirmed a positive bias of approximately 0.6 ng/mL with specific lots of the Elecsys Thyroglobulin assay
Recall Action	Recall for Product Correction
Recall Action Instructions	Affected laboratories to be aware of the potential elevated Tg recovery using this reagent lot and closely monitor internal quality control results.
Contact Information	1800 645 619 - Roche National Support Centre