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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00267-1
Product Name/Description	Liquichek Diabetes Control Master Lot Numbers: 38530, 38540, 38530V Levels: 1, 2, 3 and MiniPak Catalogue Numbers: 171, 172, 173, 172X, 291, 292, 293, 292X ARTG Number: 198363
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	27/02/2017
Responsible Entity	Bio-Rad Laboratories Pty Ltd
Reason/Issue	Bio-Rad has observed that the values for the analyte Haemoglobin A1C may gradually decrease over the shelf life of certain product lots.
Recall Action	Recall for Product Correction
Recall Action Instructions	Bio-Rad advises:- 1. Laboratory means and acceptable ranges may need to be re-established for HbA1C during the shelf life of the product; 2. Users are requested to obtain a revised copy of the Liquichek Diabetes Control package insert through the Internet at http://myeinserts.qcnet.com Discard all previous versions of the package insert for these lots of product that they may have at each location and substitute those with the revised package insert. This recall was finalised on 17/09/2018.
Contact Information	1800 224 354 - Bio-Rad Laboratories