Maputo, 17 Jul (AIM) – Mozambique’s National Medicine Regulatory Authority (ANARME) has ordered the immediate suspension of the sale and use of Rapid Diagnostic Tests (RDTs) for malaria, HIV, and HIV/syphilis manufactured by the Indian company Meril Diagnostics.
The health authority also ordered the suspension of HIVFIND home self-test.
According to ANARME statement, the decision follows the identification by the World Health Organization (WHO) and the National Institute of Health (INS) of critical failures in the manufacturer’s quality management system.
“These irregularities could compromise the reliability of results, posing a risk of incorrect diagnoses and, consequently, a risk to patient health. The tests covered by this measure are used to diagnose malaria, HIV, and syphilis”, reads the document.
These items, the document says, must be immediately withdrawn from the market as a public health protection measure. “All pharmacies, health facilities, hospitals, and distributors are prohibited from selling or using the aforementioned tests and must withdraw them and return them to their respective suppliers, in accordance with ANARME guidelines.”
The authority also calls on individuals “who possess any of these tests to immediately stop using them and seek safe diagnostic alternatives that have been duly authorized by health authorities.”
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