| 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 |
|
| 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 |