The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert over safety concerns involving certain malaria and HIV test kits manufactured by Meril Diagnostics Pvt. Ltd, India.
The warning follows a Notice of Concern (NOC) issued by the World Health Organisation (WHO) Prequalification Service after an audit of the company’s manufacturing facility.
In Public Alert No. 010/2026 released Tuesday via its X handle, NAFDAC said the WHO audit uncovered significant violations.
The agency said the 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 marketed in Nigeria by KVATH Int’l Ltd as:
Meriscreen Malaria Pf/Pv Ag
(Application No. NF-MD-341983; NAFDAC Reg. No. A3-101135)
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)
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 Marketing Authorisation Holder confirmed 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 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 refrain from distributing, selling or using the listed products.
The agency urged them to source medical devices only from authorised suppliers and verify authenticity before use.
Healthcare professionals were also asked to review existing stocks and report suspected falsified or compromised products to the nearest NAFDAC office.
The agency encouraged reporting of adverse events or side effects through its e-reporting platforms and reaffirmed its commitment to safeguarding public health through continued surveillance.
