NAFDAC WARNS AGAINST USE OF CERTAIN MERIL DIAGNOSTICS MEDICAL DEVICES IN NIGERIA
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By Aishat Momoh. O.
The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert warning healthcare providers, patients, and the general public about safety concerns surrounding specific medical devices manufactured by Meril Diagnostics Pvt. Ltd.
The alert follows a Notice of Concern (NOC) issued by the World Health Organisation (WHO) Prequalification Service, which flagged significant violations during a recent audit of the company’s manufacturing facility. NAFDAC stated that the audit “declared that the manufacturer was not operating in line with WHO requirements and applicable quality standards,” meaning the safety and quality of the devices could not be guaranteed.
The affected products, marketed in Nigeria by KVATH International Ltd, 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 registered, the Marketing Authorisation Holder confirmed that the products have not been imported into Nigeria due to the company’s current non-operational status following external policy changes. NAFDAC warned that any of these products found in the country should be considered falsified, counterfeit, and fraudulently imported.
The agency directed its zonal directors and state coordinators to remove any of the listed products from circulation and urged distributors, retailers, healthcare professionals, and caregivers to exercise extreme caution. NAFDAC also advised that all medical products be purchased only from authorised suppliers, with careful checks on authenticity and condition before use.
Healthcare professionals were asked to review hospital, clinic, and pharmacy stocks and report any suspected compromised or falsified products to the nearest NAFDAC office. The agency further encouraged reporting of adverse events or side effects through its online e-reporting platforms.
NAFDAC reaffirmed its commitment to safeguarding public health through ongoing surveillance, ensuring the quality, safety, and efficacy of medicines, medical devices, and other regulated products circulating in Nigeria.
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