Fake HIV Test Kits Flood Market, FDA Issues Urgent Health Alert

The Food and Drugs Authority (FDA) has raised a serious public health alarm over the circulation of falsified VISITECT CD4 Advanced Disease HIV test kits, warning that their use could endanger lives. According to the FDA, the counterfeit kits are capable of producing inaccurate results, which could lead to misdiagnosis, delayed treatment, and severe health complications—especially among patients who require urgent medical care. The Authority revealed that the fake products bear lot number 0001586 and falsely list Omega Diagnostics Limited, a UK-based company, as the manufacturer. However, the genuine VISITECT CD4 Advanced Disease test kits are produced by AccuBio Limited in the United Kingdom. Authentic kits carry lot number 0002172, with a manufacturing date of July 2025 and an expiry date of November 2026. In contrast, the falsified versions indicate a manufacturing date of August 2024 and an expiry date of January 2027—details the FDA says further expose their lack of credibility and safety. The FDA is urging healthcare providers and the public to remain cautious and verify the authenticity of HIV test kits before use, as efforts continue to remove the dangerous products from circulation.