Accra: The Food and Drugs Authority (FDA) has issued a public alert regarding the presence of counterfeit HIV diagnostic kits in the Ghanaian market, stressing that these kits could lead to dangerous misdiagnosis and delayed treatment.
According to Ghana Web, the FDA highlighted in a statement on its X page on April 2, 2026, that these fake products pose a significant threat to public health, especially in the realm of HIV care, where precise testing is essential. The counterfeit products have been identified as VISITECT CD4 Advanced Disease test kits with the lot number 0001586, falsely claiming Omega Diagnostics Limited as the manufacturer.
The FDA clarified that the genuine kits are actually produced by AccuBio Limited and have a different lot number, 0002172, alongside unique product specifications. The falsified kits display incorrect manufacturing and expiry dates; while the authentic kits were manufactured in July 2025 and expire in November 2026, the counterfeit versions list August 2024 as the manufacturing date and January 2027 as the expiry date.
The alert further detailed that the affected kits bear the VISITECT brand and are labeled for "CD4 Advanced Disease" testing. The packaging incorrectly lists Omega Diagnostics LTD of the United Kingdom as the manufacturer, including the company's address and telephone number. A notice on the alert explicitly states: "Manufacturer is DIFFERENT!" signifying that Omega Diagnostics is not the true source of these falsified kits.
The FDA has urged all users to return any affected kits to the nearest FDA office for safe disposal. Health professionals and the public are also encouraged to report any suspected falsified products through official channels to mitigate any potential health risks associated with these counterfeit kits.