The National Agency for Food and Drug Administration and Control has alerted healthcare providers, patients, and the public about safety concerns regarding certain medical devices manufactured by Meril Diagnostics Pvt. Ltd, India.
The alert follows a Notice of Concern issued by the World Health Organisation Prequalification Service.
In a public alert (No. 010/2026) issued on Tuesday via its X handle, NAFDAC said the NOC followed significant violations observed during a WHO Prequalification audit of the company’s manufacturing facility.
According to the agency, 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.”
NAFDAC listed the affected products, manufactured by Meril Diagnostics Pvt. Ltd and marketed in Nigeria by KVATH Int’l Ltd, the Marketing Authorisation Holder (MAH), as Meriscreen Malaria Pf/Pv Ag (Application No. NF-MD-341983; NAFDAC Reg. No. A3-101135).
Others include Meriscreen HIV 1-2 WB (Application No. NF-MD-341813; NAFDAC Reg. No. A3-101136), Meriscreen Malaria PF/PAN AG (Application No. NF-MD-342022; NAFDAC Reg. No. A3-101137), and MERISCREEN Malaria Pf HRP-II Ag (Application No. NF-MD-332483; NAFDAC Reg. No. A3-101118)
Although the products are registered, the agency said the MAH had confirmed that they had not been imported into Nigeria due to the company’s current non-operational status following external policy changes.
“It is important to note that the above-mentioned products, if found in the country, will be considered falsified, counterfeit, and fraudulently imported,” NAFDAC stated.
The agency said it had directed all zonal directors and state coordinators to conduct surveillance and remove any of the listed products found within their jurisdictions.
NAFDAC advised distributors, retailers, healthcare professionals and caregivers to exercise caution and vigilance regarding the listed products and to refrain from distributing, selling or using them.
It added that all medical products should be obtained from authorised or licensed suppliers and their authenticity and physical condition carefully checked before use.
Healthcare professionals were urged to review stocks in hospitals, clinics and pharmacy stores and report any suspected falsified or compromised products to the nearest NAFDAC office.
The agency also encouraged healthcare professionals and patients to report adverse events or side effects related to medicinal products or devices through the e-reporting platforms on its website.
NAFDAC reaffirmed its commitment to safeguarding public health through continued surveillance to ensure the quality, safety and efficacy of medicines, medical devices and other regulated products circulating in Nigeria.