NAFDAC warns of counterfeit HIV test kits circulating in Nigeria

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public warning to healthcare providers, distributors, and the general public over the circulation of counterfeit versions of the VISITECT HIV Advanced Disease Test Kits in Nigeria.

The alert was contained in a public notice published on the agency’s website, identified as Public Alert No. 011/2026, which revealed that falsified and parallel-imported unregistered versions of the diagnostic kits have been detected in the country.

According to NAFDAC, the VISITECT CD4 Advanced Disease Assay is a rapid diagnostic tool designed to identify patients with severe HIV infection.

The test, which requires no instrument, can detect dangerously low CD4 levels within about 40 minutes using a blood sample and is commonly deployed in healthcare facilities with limited medical infrastructure to identify patients who need urgent treatment.

The Marketing Authorization Holder of the product, EURO SPECS International Nigeria Limited, confirmed to the agency that counterfeit or parallel-imported versions of the kits are being distributed through unauthorized channels.

NAFDAC warned that falsified or unregistered medical products pose serious public health risks because they have not undergone regulatory evaluation to confirm their quality, safety, or effectiveness.

The agency highlighted key differences between the genuine and counterfeit products currently in circulation.

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According to NAFDAC, the authentic version of the kit is manufactured by AccuBio Ltd in Scotland and marketed in Nigeria by EURO SPECS International Nigeria Limited under NAFDAC registration number A3-100-153.

However, the counterfeit version is reportedly manufactured by Omega Diagnostics Ltd, located at Omega House, Hillfoots Business Village, Alva, Scotland, United Kingdom. The fake product carries no NAFDAC registration number and has no officially recognized marketer in Nigeria.

The agency also pointed out that the counterfeit product indicates a shelf life of three years, which contradicts the 18-month shelf life approved by NAFDAC for the genuine product. Specifically, the falsified kits show a validity period from August 2024 to January 2027.

In response, NAFDAC said it has directed all zonal directors and state coordinators across the country to intensify surveillance and remove any counterfeit or unregistered versions of the product discovered within their jurisdictions.

The agency also urged distributors, retailers, healthcare professionals, and caregivers to exercise caution by avoiding the distribution, sale, or use of unregistered medical products.

Healthcare providers were advised to immediately review their inventories in hospitals, clinics, and pharmacies and report any suspected falsified or compromised test kits to the nearest NAFDAC office.

Reports can also be made through the agency’s hotline (0800-162-3322) or via email at [email protected]

In addition, healthcare professionals and patients were encouraged to report adverse drug reactions or side effects through NAFDAC’s pharmacovigilance channels, including the Med Safety mobile application or the agency’s official website.

The warning forms part of a series of recent safety alerts issued by NAFDAC to protect public health.

The agency recently drew attention to a notice issued by the World Health Organization (WHO) Prequalification Service concerning four NAFDAC-registered diagnostic kits produced by Meril Diagnostics Pvt. Ltd in India. The notice followed violations uncovered during an audit of the company’s manufacturing facility.

NAFDAC clarified that although those products were registered, they have not been imported into Nigeria, warning that any such devices found within the country would be considered falsified and fraudulently imported.

In another development, the agency recently ordered the immediate withdrawal of multi-dose Artemether/Lumefantrine dry powder for oral suspension that is still in circulation nationwide.

It also flagged a suspected revalidated batch of SMA Gold Infant Formula discovered in Kaduna State after altered expiry dates were linked to illness in a four-month-old infant.

NAFDAC further warned about the circulation of falsified Dostinex 0.5mg tablets in Nigeria. The legitimate version of the drug is registered but has not yet been officially imported into the country, while fake batches identified as GG3470, LG8659, and GG2440 carry no NAFDAC registration and may pose health risks.

The agency reiterated its commitment to protecting public health by strengthening surveillance and regulatory enforcement against counterfeit and substandard medical products.