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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 Inverness Medical Innovations Australia Pty Ltd T/A Alere
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