NAFDAC warns against 4 malaria/HIV kits after WHO quality audit
NAFDAC issued a public alert cautioning healthcare providers and the public against using four malaria and HIV diagnostic kits following a WHO audit finding significant violations at Meril Diagnostics' Indian manufacturing facility. The WHO Prequalification service (WHO-PQT) identified the manufacturer was not operating in line with international quality standards. Although NAFDAC previously registered the products, the agency stressed their quality and safety are not guaranteed due to the WHO findings. The affected products are Meriscreen Malaria Pf/Pv Ag (A3-101135), Meriscreen HIV 1-2 WB (A3-101136), Meriscreen Malaria PF/PAN AG (A3-101137), and MERISCREEN Malaria Pf HRP-II Ag (A3-101118), manufactured by Meril Diagnostics and marketed in Nigeria by KVATH International. Despite registration, NAFDAC confirmed the kits have not been imported into Nigeria. The agency warned that if found, they would be considered falsified or counterfeit. NAFDAC directed intensified surveillance to remove any listed products and urged distributors, retailers, and healthcare professionals to avoid using or distributing them. Contact: Report via 0800-162-3322 or [email protected].