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Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00732-1
Product Name/Description	qUAntify Control / qUAntify Plus Control. An in vitro diagnostic medical device (IVD). Catalogue Numbers: 975, 975X, 995, 995X (12 mL), 962, 963, 964, 962X (120 mL) Lot Numbers: 78770, 78780, 80510, 80520, 80530, 80540, 80550, 80560, 79610, 79620, 79630, 79640, 79650, 79660 ARTG Number: 206309 Bio-Rad Laboratories - Clinical chemistry biological screening IVDs
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	15/06/2018
Responsible Entity	Bio-Rad Laboratories Pty Ltd
Reason/Issue	Bio-Rad have observed that the values for Blood and Ketones may gradually decrease, and values for pH may gradually increase over the shelf life of affected product lots. This issue is not expected to impact patient results.
Recall Action	Product Defect Correction
Recall Action Instructions	Bio-Rad is advising users that the package insert has been updated to specify the changing values for these analytes. Laboratory means and acceptable ranges may need to be re-established for Blood, Ketones and pH during the shelf life of the product. This action has been closed out on 25/09/2018
Contact Information	1800 224 354 - Bio-Rad Laboratories