FDA warns of fake HIV test kits on Ghanaian market
The Food and Drugs Authority (FDA) has issued a public health alert after discovering falsified HIV diagnostic kits being sold in Ghana. The alert raises concerns about the risk of wrong test results and delayed treatment. The Authority identified the affected products as VISITECT CD4 Advanced Disease test kits with lot number 0001586.
The FDA explained that these kits are counterfeit and do not meet approved standards. The fake kits wrongly list Omega Diagnostics Limited as the manufacturer. The genuine VISITECT CD4 test kits are produced by AccuBio Limited and carry a different lot number, 0002172, along with proper product details. The falsified kits show incorrect manufacturing and expiry dates. The original kits were manufactured in July 2025 and are due to expire in November 2026, but the fake versions indicate August 2024 as the manufacturing date and January 2027 as the expiry date. The FDA noted that "Your health is too important to risk," calling for increased vigilance across the health sector.
The FDA has directed all hospitals, laboratories, and testing centres to check their stock of VISITECT CD4 test kits and remove any kits with lot number 0001586 from use at once. The Authority instructed that such products should be returned to the nearest FDA office for proper disposal. The FDA has begun investigations to trace the source of the falsified kits and ensure those responsible are held accountable.
Quick Summary
The FDA has issued a warning about falsified HIV diagnostic kits being sold in Ghana- raising concerns among healthcare providers. The use of these kits could have far-reaching implications for public health and safety.
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