NAFDAC alerts public to counterfeit HIV diagnostic test kits circulating in Nigeria
The National Agency for Food and Drug Administration and Control has warned healthcare providers and the public about the circulation of counterfeit versions of VISITECT HIV Advanced Disease Test Kits in Nigeria.
The National Agency for Food and Drug Administration and Control has warned healthcare providers and the public about the circulation of counterfeit versions of VISITECT HIV Advanced Disease Test Kits in Nigeria.
This was disclosed in a public notice published on the agency’s website.
The alert, issued as Public Alert No. 011/2026, said counterfeit and parallel-imported unregistered versions of the test kits have been identified in the country.
According to the agency, VISITECT CD4 Advanced Disease assay is a rapid diagnostic test used to identify patients with severe HIV infection. The instrument-free test can detect low CD4 levels within about 40 minutes using blood samples and is commonly used in settings with limited medical infrastructure to determine patients who require urgent treatment.
NAFDAC also highlighted discrepancies between the genuine and counterfeit versions of the product.
NAFDAC also noted that the counterfeit product carries a three-year shelf life, from August 2024 to January 2027, while the genuine version approved by the agency has an 18-month shelf life.
NAFDAC said all zonal directors and state coordinators have been directed to carry out surveillance and remove any counterfeit or unregistered versions of the product found within their jurisdictions.
Healthcare professionals and patients are also encouraged to report adverse drug reactions or side effects through NAFDAC’s pharmacovigilance platforms, including the Med-Safety mobile application or the agency’s website.
NAFDAC recently alerted Nigerians to a Notice of Concern issued by the World Health Organization’s Prequalification Service over four NAFDAC-registered diagnostic kits manufactured by Meril Diagnostics Pvt. Ltd in India after violations were identified during an audit of the company’s manufacturing facility.
The agency said that although the products were registered, they have not been imported into Nigeria and warned that if any of the devices are found in circulation in the country would be considered falsified and fraudulently imported.
Another is on the circulation of falsified Dostinex 0.5mg tablets in Nigeria. The legitimate product is registered but not yet imported, while the fake batches, GG3470, LG8659, and GG2440 have no NAFDAC registration and may be unsafe
