| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01298-1 |
| Product Name/Description |
Freelite Human Kappa Free Kit (use on the Beckman AU (400, 480, 640, 680, 2700, 5400) Series). An in vitro diagnostic medical device (IVD)
Item Number: TBSLK016AU
Lot Number: 358004
ARTG Number: 202167 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
It was determined through the course of a post-release product investigation that the control values on an affected lot of the Freelite Human Kappa Free Kit require a reassignment which is 21% lower than the value established during the manufacture of the product. With the currently assigned values, if the controls are out of range (±20% of the concentration stated), then results of the run should not be accepted, which may lead to a delay in reporting results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In Vitro Technologies are providing users with revised values for the quality controls, which are to be used for the remainder of the shelf life of the Freelite Human Kappa Free Kit. This action has been closed out on 14 June 2017. |
| Contact Information |
1300 552 003 - In Vitro Diagnostics |