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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00967-1
Product Name/Description Panbio Barmah Forest Virus IgM ELISA. An in vitro diagnostic medical device (IVD).

Catalogue Numbers: E-BFV01M & E-BFV01M05

Lot Numbers:12354, 13051 & 13140

ARTG Number: 22341
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/09/2013
Responsible Entity Inverness Medical Innovations Australia Pty Ltd T/A Alere
Reason/Issue Investigations have determined that the affected lot numbers may yield an increased number of false-positive results. Performance testing has concluded that there has been a shift in the sero-epidemiology of the patient population currently being tested. Use of this product on an automated system may further increase the proportion of false positive results.
Recall Action Recall
Recall Action Instructions Alere is requesting their customers to discontinue and destroy all remaining affected lots. Replacement product is expected to be available in 1 - 2 weeks. Customers are advised to consult with their resident clinical expert or doctor, if they question any previously reported results.
Contact Information 07 3363 7711 - Alere Technical Support