The National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria has raised a safety alert concerning specific medical devices produced by India's Meril Diagnostics Pvt. Ltd., particularly those related to malaria and HIV testing. This warning is a result of a Notice of Concern (NOC) issued by the World Health Organisation (WHO) following significant violations identified during a prequalification audit of the company's manufacturing facility. The NOC indicates that the manufacturer was non-compliant with WHO standards and other applicable quality regulations.

NAFDAC detailed its findings in a public alert (No. 010/2026) distributed via its social media platform, warning healthcare providers, patients, and the general public that the quality and safety of the medical devices in question cannot be assured. The alert specifically identifies several affected products marketed in Nigeria by KVATH International Ltd., the Marketing Authorisation Holder. Among these is the Meriscreen Malaria Pf/Pv Ag kit, highlighting the potential risks associated with the use of these test kits in the diagnosis and treatment of malaria.

The implications of this alert are significant for public health, as inaccurate or unreliable testing devices can lead to misdiagnosis and improper treatment of malaria and HIV, exacerbating health issues in communities reliant on these diagnostics. NAFDAC's proactive measure underscores the importance of regulatory oversight in ensuring the safety and efficacy of medical devices in Nigeria, particularly those sourced from international manufacturers during health emergencies.