|Type of Product
|TGA Recall Reference
||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
|Recall Action Classification
|Recall Action Commencement Date
||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 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.
||07 3363 7711 - Alere Technical Support