| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01216-1 |
| Product Name/Description |
Alere Determine HIV-1/2 Ag/Ab Combo (an in vitro diagnostic medical device)
Catalogue Number: DT7D2646
All lots within expiry affected
ARTG Number: 203911 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
This action is being initiated as a result of Alere’s post market surveillance activity. Specifically, negative results were obtained from a single sample in the EQA Ring Trial in Europe. This sample was taken from a 40 year old man with a 7 day history of fever, rash and fatigue and contained p24 antigen of a virus of subtype C at a concentration of 250 pg / mL (viral load of 2,500,000 copies / mL), corresponding to 50 IU / mL (WHO standard). A recent publication of a survey conducted in Swaziland also suggested that the antigen component of the Alere Determine HIV-1/2 Ag/Ab Combo test in a high-prevalence, high-incidence setting was unable to detect acute infection in this subtype C population. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Alere is notifying hospitals of the following additional assay limitations:
- The test is designed to provide an additional, rapid testing option for the detection of HIV infections. The sensitivity of the Alere Determine HIV-1/2 Ag/Ab Combo is not equivalent to 4th generation HIV ELISA, p24 EIA or PCR, which limits its ability to detect acute infections in comparison to those methods.
- Where clinical presentation or other data would suggest an inconsistent result then the patient should be tested by PCR and/or retested for antibodies to HIV >21 days after the original testing. This action has been closed-out on 18/03/2016. |
| Contact Information |
07 3363 7711 - Alere Technical Support |