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Nigeria’s drug regulator has warned healthcare providers and the public about counterfeit and parallel-imported versions of VISITECT HIV Advanced Disease Test Kits circulating in the country.
The National Agency for Food and Drug Administration and Control (NAFDAC) issued the warning on Wednesday in a notice titled Public Alert No. 011/2026, published on its official X account.
According to the agency, the marketing authorisation holder for the product in Nigeria, Euro Specs International Nigeria Limited, confirmed that counterfeit and unregistered versions of the diagnostic kit are being sold through unauthorised channels.
NAFDAC said the VISITECT CD4 Advanced Disease assay is a rapid, instrument-free lateral flow test designed to identify patients with severe HIV infection, defined by a CD4 count below 200 cells per microlitre, within about 40 minutes using a blood sample.
The agency described the test as a critical diagnostic tool in resource-limited settings, adding that it helps healthcare workers quickly identify patients who require urgent advanced care.
However, it warned that falsified and unregistered medical products pose serious risks to public health because they have not undergone regulatory evaluation.
“Falsified, unlicensed and unregistered products have not been evaluated and approved by NAFDAC. Their quality, safety and efficacy cannot therefore be guaranteed,” the agency said.
NAFDAC pointed out several discrepancies between the genuine product and the counterfeit version currently in circulation.
It said the authentic VISITECT CD4 Advanced Disease test kit is manufactured by AccuBio Ltd in Alva, Scotland, United Kingdom (UK), and marketed in Nigeria by Euro Specs International Nigeria Limited with the NAFDAC registration number A3-100-153.
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By contrast, the counterfeit version lists Omega Diagnostics Ltd., also based in Alva, Scotland, as the manufacturer, carries no NAFDAC registration number and is marketed by an unidentified distributor.
The regulator also pointed to differences in product labelling, revealing that the genuine kit bears Lot Number 0002172, IFU Version 1, a manufacturing date of July 30, 2025, and an expiry date of November 30, 2026.
NAFDAC disclosed that the suspected counterfeit product carries Lot Number 0001586, IFU Version 3, with a manufacturing date of August 2024 and an expiry date of January 2027.
It explained that the counterfeit label indicates a three-year shelf life, from August 2024 to January 2027, compared with the 18-month shelf life approved for the registered product.
The agency said its zonal directors and state coordinators have been instructed to intensify surveillance and remove any counterfeit or unregistered kits found within their jurisdictions.
Distributors, retailers, healthcare professionals and caregivers were advised to remain vigilant and ensure that all medical products are sourced from authorised and licensed suppliers.
NAFDAC also urged the public to report adverse reactions or suspicious products through its e-reporting platforms on the agency’s website, via the Med-Safety mobile application, or by email to pharmacovigilance@nafdac.gov.ng.
The agency added that the alert would also be uploaded to the World Health Organisation’s Global Surveillance and Monitoring System.
The warning follows a separate safety notice issued by NAFDAC a day earlier over questions about certain malaria and HIV diagnostic kits and other medical devices produced by Meril Diagnostics Pvt. Ltd in India.