The National Agency for Food and Drug Administration and Control (NAFDAC) has raised an alert over the circulation of counterfeit and unregistered versions of the VISITECT HIV Advanced Disease Test Kits in Nigeria, warning healthcare providers and the public to exercise caution.
In a notice titled Public Alert No. 011/2026 shared via its official X account, the agency said the counterfeit products were discovered following confirmation from the product’s Marketing Authorisation Holder in Nigeria, Euro Specs International Nigeria Limited.
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According to NAFDAC, the VISITECT CD4 Advanced Disease assay is a rapid, instrument-free diagnostic test used to identify patients with advanced HIV disease, particularly those with CD4 counts below 200 cells/µL. The test delivers results within 40 minutes using blood samples and is considered crucial for triaging patients who require urgent care in resource-limited settings.
The agency explained that falsified and unregistered medical products pose serious risks to public health because they have not been evaluated or approved for safety, quality, or effectiveness.
NAFDAC stated that the genuine test kit is manufactured by AccuBio Ltd in Scotland and marketed in Nigeria by Euro Specs International Nigeria Limited with NAFDAC Registration Number A3-100-153. However, the counterfeit version lists Omega Diagnostics Ltd as the manufacturer, carries no NAFDAC registration number, and is marketed by an unknown distributor.
The agency also identified differences in lot numbers, manufacturing and expiry dates, and shelf life between the authentic and counterfeit products.
NAFDAC said it has directed its zonal directors and state coordinators to intensify surveillance and remove any counterfeit products from circulation.
It also urged healthcare professionals and distributors to source medical products only from authorised suppliers and report suspicious products through its pharmacovigilance platforms.
