FDA flags dangerous fake HIV test kits in Ghana
The Food and Drugs Authority (FDA) has issued an urgent public health warning about the circulation of falsified VISITECT CD4 Advanced Disease HIV test kits, cautioning that their use could endanger patient safety and compromise care.
The regulator highlighted that these counterfeit kits may give inaccurate results, potentially causing misdiagnosis, delayed treatment, and severe health risks, especially for patients who need prompt medical intervention.
The FDA noted that the fake products bear lot number 0001586 and falsely list Omega Diagnostics Limited of the United Kingdom as the manufacturer.
By contrast, genuine VISITECT CD4 Advanced Disease test kits are produced by AccuBio Limited in the UK, with lot number 0002172 and specific product features.
The authentic kits have a manufacturing date of July 2025 and expire in November 2026, while the counterfeit versions incorrectly state August 2024 as the manufacturing date and January 2027 as the expiry date, raising serious concerns about their reliability and safety for clinical use.
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