The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public warning about counterfeit and unregistered versions of the VISITECT HIV Advanced Disease Test Kits circulating in Nigeria.
According to NAFDAC Public Alert No. 011/2026, the Marketing Authorisation Holder (MAH), EURO SPECS International Nigeria Limited, confirmed that fake and parallel-imported kits are being sold through unauthorized channels.
The VISITECT CD4 Advanced Disease assay is a rapid, instrument-free lateral flow test that identifies patients with severe HIV (CD4 count below 200 cells/µL) in just 40 minutes. It is an essential diagnostic tool in resource-limited settings, helping healthcare providers prioritize patients requiring urgent advanced care.
The legitimate product is known for its high sensitivity in detecting low CD4 levels.
NAFDAC notes a key difference between genuine and counterfeit kits: the fake versions display a three-year shelf life from August 2024 to January 2027, whereas the approved shelf life is only 18 months.
Healthcare professionals are urged to review stocks in hospitals, clinics, and pharmacies. Anyone who encounters suspected falsified or compromised products is advised to report them to the nearest NAFDAC office, call 0800-162-3322, or email sf.alert@nafdac.gov.ng.
