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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