The National Agency for Food and Drug Administration and Control has alerted healthcare providers and the public to a Notice of Concern (NOC) issued by the World Health Organisation (WHO) Prequalification Service on certain NAFDAC-registered medical devices.
In a statement on its official X handle on Tuesday, NAFDAC said the affected products were manufactured by Meril Diagnostics Pvt. Ltd., India.
The agency explained that the action followed significant violations observed during a WHO prequalification audit of the company’s manufacturing facility.
NAFDAC stated that the violations led to a declaration that the manufacturer was not operating in compliance with WHO requirements and applicable quality standards, raising concerns about the devices’ quality and safety.
The affected products include Meriscreen Malaria Pf/Pv Ag (Application No. NF-MD-341983, Reg. No. A3-101135) and Meriscreen HIV 1-2 WB (NF-MD-342022, Reg. No. A3-101136).
Others are Meriscreen Malaria PF/PAN AG (NF-MD-342022, Reg. No. A3-101137) and Meriscreen Malaria Pf HRP-II Ag (NF-MD-332483, Reg. No. A3-101118).
NAFDAC said that although the products were registered, the marketing authorisation holder, KVATH Int’l Ltd., confirmed they had not been imported into Nigeria due to the company’s current non-operational status following external policy changes.
The agency warned that any of the listed products found in Nigeria would be considered falsified, counterfeit, and fraudulently imported.
NAFDAC said it had directed all zonal directors and state coordinators to intensify surveillance and remove any such products from circulation, reaffirming its commitment to safeguarding public health.
It urged distributors, retailers, healthcare professionals, and caregivers to exercise caution and refrain from distributing, selling, or using the affected devices.
(NAN)
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