| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00049-1 |
| Product Name/Description |
Sofia Influenza A+B FIA Kit. An in vitro diagnostic medical device (IVD)
Catalogue Number: 20218
Lot number range: 208228-214385 and 707916-708108 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
This recall has been initiated due to false positive results which may lead to misdiagnosis. Sofia Influenza A+B FIA Kit has only been supplied in Australia for customer evaluation. No patient results have been reported.
This recall action was not notified to the TGA before it was initiated by Vital Diagnostics. |
| Recall Action |
Recall |
| Recall Action Instructions |
Vital Diagnostics is requesting customers to destroy any kits from the affected lots. Vital Diagnostics will supply replacement kits if required. |
| Contact Information |
02 9894 6988 - Vital Diagnostics |