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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 Vital Diagnostics Manufacturing Pty Ltd
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