| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01425-1 |
| Product Name/Description |
Freelite Human Lambda Free kit for use on SPAPLUS
Item Numbers: TBSLK018S, TBSLK01810S
Lot Numbers: 400012, 400257
Expiry: Nov 2017 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has advised that investigations of the products have identified a change in the calibration curve shape that has occurred since product release. Increased activity in the calibration curve between calibrators 5 and 6 has been observed and they have received reports of increased false prozone flags which is consistent with this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to immediately quarantine and dispose of any affected lots held by the customers and also to remove any affected lots from the SPAPLUS instrument. It is also advised to discuss the issues with the Medical Director to identify any further actions are required including reviewing the previously reported results.
This action has been closed out on 30/10/2018 |
| Contact Information |
1300 552 003 - In Vitro Technologies |