NAFDAC flags WHO notice on Meril Diagnostics’ medical devices
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)
We have recently deactivated our website's comment provider in favour of other channels of distribution and commentary. We encourage you to join the conversation on our stories via our Facebook, Twitter and other social media pages.
More from Peoples Gazette
Agriculture
FG tasks ECOWAS on leveraging financing strategies for agroecology
The federal government has urged stakeholders in the agriculture and finance sectors in the West Africa region to leverage financing strategies to enhance agroecology practices
Politics
Katsina youths pledge to deliver over 2 million votes to Atiku
“Katsina State is Atiku’s political base because it is his second home.”
Lagos
Residents count losses as floods destroy homes, businesses in Lagos communities
Lagos residents count losses as rain floods homes across several communities in the state.
Lagos
Lagos police nab suspect over alleged N3 billion cyber fraud
Mr Ewhubare said the suspect was apprehended following an extensive investigation into a sophisticated cyber intrusion targeting a financial institution.
Africa
Xenophobia: Uganda repatriates 1,102 citizens from South Africa
The Ugandan embassy said, “The arrival marks the successful conclusion of phase one of the government of Uganda’s voluntary repatriation exercise.”
NationWide
CSOs urge assessment of National Assembly’s proposed electoral college for women legislators
“The proposal is unfamiliar to many stakeholders and understandably raises concerns, but we must carefully interrogate it instead of dismissing it outright,” he said.
Hot news Home top
Ryanair passenger partly sucked out of Boeing 737 plane as window dislodges after take-off
A witness said a passenger’s head and shoulders were sticking out of the broken window, and fellow passengers managed to pull him back inside the aircraft.
Lagos
LG chairman bans indiscriminate placement of banners, posters at Badagry roundabout
“This will also improve visibility for motorists, prevent obstruction of traffic signs and maintain the aesthetic of one of Badagry’s busiest gateway corridors,” he said.
