Medical device manufacturer, Alere, has issued a medical device safety alert concerning its SD BIOLINE HIV Ag/Ab Combo [Product codes: 03FK30, 03FK35; Lot numbers: 03BDA003A, 03BDA004A, 03BDA005A, 03BDA006A, 03BDA006B, 03BDB001A, 03BDB001B, 03BDB001C, 03BDB002A].
The manufacturer has received two performance complaints of SD NIOLINE HIV Ag/Ab Combo in February 2017 from Kyrgyzstan. They investigated the complaints and confirmed that the affected lots did not meet the performance claim for analytical sensitivity of p24 antigen (Claimed detection limit in the package insert: 2IU/ml, however the affected lots detect a concentration of 16 IU/ml.
According to the manufacturer, when performing as expected, the p24 component of the assay may enable the detection of the infection about 7 days before the antibody results become positive. If a patient is in very early diagnostic window period, the lower p24 sensitivity of the affected lots may reduce the detection period by one or two days, with the possibility of a false negative result.
If a false negative result occurs, it is possible that treatment of a patient that is HIV positive could be delayed and further transmission of the infection to sexual partners or through blood transfusion could occur.
The users are advised to take the following actions:
According to the local supplier, the affected products are distributed in Hong Kong and product recall is on-going. There was no adverse event reported.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 5 May 2017