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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00146-1
Product Name/Description Liquichek Specialty Immunoassay Controls. An in vitro diagnostic medical device (IVD)

Master Lot Numbers:
57430, 57440, 57450, 57460, 57470, 57480, and 57490

ARTG Number: 194959
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 8/02/2016
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue Bio-Rad have observed that Intact PTH may not meet the thawed unopened and thawed open vial stability claims as printed in the package inserts. There is a possibility that intact PTH values in the lots affected may gradually shift down due to a decrease in stability when the product is stored at 2 to 8°C. The claims for Intact PTH have been revised from 23 days to 7 days.
Although unlikely, the reported issue may result in a delay in result reporting or the false signalling of an in-control situation.
Recall Action Recall for Product Correction
Recall Action Instructions Bio-Rad is advising users not to use the control for intact PTH beyond 7 days when stored at 2 to 8°C. Users are able to obtain a revised package insert with the updated stability time frames from
Contact Information 1800 224 354 - Bio-Rad Laboratories