The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a warning to healthcare providers and the public over the circulation of counterfeit VISITECT HIV Advanced Disease Test Kits in Nigeria.
The alert, published as Public Alert No. 011/2026, indicates that counterfeit and parallel-imported unregistered versions of the kits have been detected in the country. The VISITECT CD4 Advanced Disease assay is a rapid diagnostic test that identifies patients with severe HIV infection. It works without instruments and can detect low CD4 levels within 40 minutes, making it particularly important in low-resource healthcare settings.
The Marketing Authorization Holder, EURO SPECS International Nigeria Limited, confirmed the presence of counterfeit and parallel-imported versions distributed through unauthorized channels. NAFDAC emphasized that falsified or unregistered medical products pose serious risks, as they have not been evaluated for quality, safety, or effectiveness.
NAFDAC outlined the differences between genuine and counterfeit kits:
Genuine version: Manufactured by AccuBio Ltd, Scotland; marketed in Nigeria by EURO SPECS International Nigeria Limited; NAFDAC registration number A3-100-153; 18-month shelf life.
Counterfeit version: Manufactured by OMEGA DIAGNOSTICS LTD, Scotland; no NAFDAC registration; shelf life of three years (Aug 2024 – Jan 2027), which contradicts the approved 18 months.
The agency also reminded the public of previous alerts regarding falsified medical products, including diagnostic kits from Meril Diagnostics Pvt. Ltd, multi-dose Artemether/Lumefantrine, SMA Gold infant formula with altered expiry dates, and Dostinex 0.5mg tablets circulating without registration.
NAFDAC urged health facilities, pharmacies, and patients to verify products before use and report suspicious items to the agency to prevent health risks associated with counterfeit medical devices.
