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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
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