FDA warns of falsified HIV test kits on the market

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The Food and Drugs Authority (FDA) of Ghana has issued an urgent public health alert regarding the circulation of falsified VISITECT CD4 Advanced Disease HIV test kits.

The FDA warns that these counterfeit kits may give inaccurate results, potentially leading to misdiagnosis, delayed treatment, and serious health risks—particularly for vulnerable patients.

According to the Authority, the fake kits carry lot number 0001586 and falsely list Omega Diagnostics Limited as the manufacturer.

The FDA clarified that genuine VISITECT CD4 test kits are manufactured by AccuBio Limited under lot number 0002172, with a manufacturing date of July 2025 and an expiry date of November 2026. In contrast, the counterfeit products indicate a manufacturing date of August 2024 and an expiry date of January 2027, raising concerns about their safety and reliability.

The FDA is urging healthcare providers and the public to remain vigilant and report any suspected falsified products to help prevent potential harm.

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