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.
What NAFDAC said
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.
- The Marketing Authorization Holder of the product, EURO SPECS International Nigeria Limited, confirmed the existence of counterfeit or parallel-imported versions being distributed through unauthorized channels.
- The agency warned that falsified or unregistered medical products pose serious risks because they have not been evaluated for quality, safety, or effectiveness.
NAFDAC also highlighted discrepancies between the genuine and counterfeit versions of the product.
- “The registered version is manufactured by AccuBio Ltd in Scotland and marketed in Nigeria by EURO SPECS International Nigeria Limited with NAFDAC registration number A3-100-153.
- “By contrast, the counterfeit version is manufactured by OMEGA DIAGNOSTICS LTD., Omega House Hillfoots Business Village Alva, FK 12 5DQ, Scotland, United Kingdom, carries no NAFDAC registration number and marketer, it also displays a shelf life of three years, which contradicts the 18-month shelf life approved by the agency,” the agency stated
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.
More details
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.
- The agency also advised distributors, retailers, healthcare professionals, and caregivers to exercise caution and avoid distributing, selling, or using unregistered medical products.
- Healthcare providers have been asked to review stocks in hospitals, clinics, and pharmacies and report any suspected falsified or compromised products to the nearest NAFDAC office.
Reports can also be made through the agency’s hotline 0800-162-3322 or via email at sf.alert@nafdac.gov.ng
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.
What you should know
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.
- In another safety alert, NAFDAC recently directed the immediate withdrawal of multi-dose Artemether/Lumefantrine dry powder for oral suspension still in circulation across the country.
- The agency also flagged a suspected revalidated SMA Gold infant formula discovered in Kaduna State after altered expiry dates were linked to illness in a four-month-old infant.
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
