| 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 |
|
| 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 http://myeinsters.qcnet.com |
| Contact Information |
1800 224 354 - Bio-Rad Laboratories |