| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00231-1 |
| Product Name/Description |
Freelite Human Kappa Integra Kit. An in vitro diagnostic medical device (IVD)
Item Numbers: TBSLK01610RI and TBSLK016I
Lot Numbers: 354992, 355769
ARTG Number: 202167 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has determined that the affected calibrator and controls require a reassignment which is 16% lower than the value established during the manufacture of this product. In Vitro Technologies is advising users to recalibrate the affected lots with the new calibrator values provided. The assay bias of 16% would result in a minimal change to low values. However the difference would be proportionately greater at higher values. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In Vitro Technologies is providing users with revised target and range values to be used with the affected kits. The Director of Chemical Pathology should be consulted to determine the need for a review of results previously reported using this kit
This action has been closed-out on 22/03/2018. |
| Contact Information |
1300 552 003 - In Vitro Technologies |