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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01106-1
Product Name/Description	Panbio Barmah Forest Virus IgM ELISA (An in vitro diagnostic medical device (IVD)) Catalogue Number: E-BFV01M, E-BFV01M05 Lot Number: 13234 ARTG Number: 22341
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	25/10/2013
Responsible Entity	Inverness Medical Innovations Australia Pty Ltd T/A Alere
Reason/Issue	Internal investigations of the affected lot number indicate that the performance of this lot may change over time leading to an increased number of false positive results.
Recall Action	Recall
Recall Action Instructions	Alere is requesting their customers to discontinue and destroy all remaining affected lots. Alere is advising users to consult with their resident clinical expert or doctor, if they question any previously reported results.
Contact Information	07 3363 7711 - Alere Technical Support