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NAFDAC alerts Nigerians to counterfeit VISITECT HIV test kits in the market.
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Fake kits lack NAFDAC registration number and carry altered manufacturing details.
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Agency orders nationwide surveillance and urges purchase from authorised suppliers only.
The National Agency for Food and Drug Administration and Control (NAFDAC) has raised alarm over the circulation of counterfeit and parallel-imported unregistered versions of the VISITECT CD4 Advanced Disease HIV test kits in Nigeria.
In a public alert issued on Wednesday, the agency disclosed that the Marketing Authorisation Holder, Euro Specs International Nigeria Limited, confirmed that fake versions of the diagnostic kits are being distributed through unauthorised channels.
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NAFDAC explained that the genuine VISITECT CD4 Advanced Disease assay is a rapid, instrument-free test designed to detect severe HIV cases — specifically patients with CD4 counts below 200 cells/µL — within 40 minutes using blood samples.
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The test is particularly vital in resource-limited settings, where early detection helps prioritise patients requiring urgent advanced care.
According to the agency, falsified and unregistered medical products pose serious public health risks because they have not undergone regulatory evaluation for safety, quality or effectiveness.
The authentic product is manufactured by AccuBio Ltd in Scotland and marketed in Nigeria by Euro Specs International Nigeria Limited, with NAFDAC Registration Number A3-100-153. However, the counterfeit version lists a different manufacturer, carries no NAFDAC registration number, and is marketed by an unidentified entity.
NAFDAC further highlighted discrepancies in lot numbers, manufacturing dates, expiry dates and shelf life.
While the genuine product has an approved 18-month shelf life, the counterfeit version falsely indicates a three-year validity period.
The agency has directed its zonal directors and state coordinators to intensify market surveillance and remove any fake or unregistered products found in circulation.
It also advised distributors, healthcare providers and caregivers to verify product authenticity and source medical supplies strictly from licensed vendors.
NAFDAC encouraged the public to report adverse reactions or suspicious products through its official e-reporting platforms and assured that the alert would also be uploaded to the World Health Organisation’s Global Surveillance and Monitoring System.
The warning comes barely 24 hours after the agency raised safety concerns over certain malaria and HIV diagnostic kits produced by an Indian manufacturer.