The National Agency for Food and Drug Administration and Control (NAFDAC) has raised alarms over the safety of some medical devices manufactured by Meril Diagnostics Pvt. Ltd, India, cautioning healthcare providers, patients, and the general public.
The alert follows a Notice of Concern (NOC) issued by the World Health Organization Prequalification Service, after significant violations were detected during an audit of Meril Diagnostics’ manufacturing facility.
In its public advisory (No. 010/2026) shared on Tuesday via its X handle, NAFDAC explained, “The audit findings led to a declaration that the manufacturer was not operating in line with WHO requirements and applicable quality standards. Hence, the quality and safety of the medical devices are not guaranteed.”
The affected products, marketed in Nigeria by KVATH Int’l Ltd as the Marketing Authorisation Holder (MAH), include:
• Meriscreen Malaria Pf/Pv Ag (NAFDAC Reg. No. A3-101135)
• Meriscreen HIV 1-2 WB (NAFDAC Reg. No. A3-101136)
• Meriscreen Malaria PF/PAN AG (NAFDAC Reg. No. A3-101137)
• MERISCREEN Malaria Pf HRP-II Ag (NAFDAC Reg. No. A3-101118)
Although these devices are registered, the MAH confirmed that they have not been imported into Nigeria due to the manufacturer’s current non-operational status following policy changes abroad.
NAFDAC warned, “It is important to note that the above-mentioned products, if found in the country, will be considered falsified, counterfeit, and fraudulently imported.”
The agency has directed all zonal directors and state coordinators to conduct surveillance and remove any of the listed products discovered in their jurisdictions.
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Healthcare providers, distributors, retailers, and caregivers were urged to exercise caution, refrain from selling, distributing, or using the devices, and ensure that all medical products are sourced from licensed and authorised suppliers.
NAFDAC further advised, “Healthcare professionals are encouraged to review stocks in hospitals, clinics, and pharmacy stores and report any suspected falsified or compromised products to the nearest NAFDAC office. Patients and professionals should also report any adverse events or side effects through the e-reporting platforms on our website.”
The agency reaffirmed its commitment to protecting public health, emphasizing ongoing surveillance to ensure the quality, safety, and efficacy of medicines, medical devices, and other regulated products circulating in Nigeria.