Public Alert No. 011/2026 – Alert on the Counterfeit Version of VISITECT HIV Advanced Disease Test Kits Identified in Nigeria

The National Agency for Food and Drug Administration and Control (NAFDAC) is warning healthcare providers, patients, and the public about reports of counterfeit and parallel-imported unregistered versions of the VISITECT HIV Advanced Disease Test Kits circulating in Nigeria.

The Marketing Authorization Holder (MAH) of the products (EURO SPECS International Nigeria Limited) has confirmed the existence of counterfeit/parallel imported unregistered versions of the products, which are sold through unauthorized channels.

The VISITECT CD4 Advanced Disease assay is a rapid, instrument-free lateral flow test designed to identify patients with severe HIV (CD4 count < 200 cells/µL) within 40 minutes using blood samples. This assay is a vital diagnostic tool for resource-limited settings, helping to triage patients who require immediate advanced care. It offers high sensitivity in detecting low CD4 levels.

Risk Statement

The integrity of regulated products relies heavily on adherence to regulatory requirements. Falsified, unlicensed, and unregistered products pose significant risks to public health, as these products have not been evaluated by NAFDAC. Therefore, the quality, safety, and efficacy of such products cannot be guaranteed.

The key discrepancies identified between the genuine version (EURO SPECS International Nigeria Limited) and the counterfeit version are as follows:

Note: The product label of the counterfeit version displays a three (3) year shelf-life 2024-08 – 2027-01 as against an eighteen (18) months shelf-life approved by NAFDAC.

Product Photo

Fig 1: Approved VISITECT CD4 Advanced Disease Test Kit Photo

Fig 2 & 3: Counterfeit/Unregistered VISITECT CD4 Advanced Disease Test Kit Photo

NAFDAC remains committed to safeguarding public health and will continue surveillance activities to ensure the quality, safety, and efficacy of medicines, medical devices, and other regulated products circulating in Nigeria.

All NAFDAC zonal directors and state coordinators have been instructed to conduct surveillance and remove any counterfeit or unregistered products found within their zones and states.

Distributors, retailers, healthcare professionals, and caregivers are advised to be aware of the discrepancies mentioned and to exercise caution and vigilance throughout the supply chain to prevent the distribution, sale, and use of unregistered products. It is essential to obtain all medical products from authorized and licensed suppliers, and to carefully verify the authenticity and physical condition of these products.

Healthcare professionals are advised to review stocks within hospitals, clinics, and pharmacy stores, report any suspected falsified or compromised products (medicines or medical devices) to the nearest NAFDAC office, NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng

Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med-safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng

For complaints, you can call the Reforms Unit on the following lines: 09097630506, 09097630507, or email: reforms@nafdac.gov.ng

Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).

NAFDAC………. Customer-focused, Agency-minded!!!