| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01194-1 |
| Product Name/Description |
ENA RELISA Single Well Screen (576 well) Kit. An in vitro diagnostic medical device (IVD)
Product Code: IC7696-10
Lot Numbers:1525909 and 1525812
ARTG Number: 197980 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
Diagnostic Solutions has been informed by Immuno Concepts that incorrect calibrator has been included with affected lots of the ENA RELISA Single Well screen kits. This may result in over-sensitivity and false positive patient results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Diagnostic Solutions is advising users to inspect stock and destroy any remaining kits of the affected lots.
Diagnostic Solutions is recommending that a review of previously reported results is performed at the discretion of the Laboratory Director. This action has been closed-out on 25/08/2016. |
| Contact Information |
1300 788 003 - Diagnostic Solutions Customer Service |