Els: MBN360 Health
The Food and Drugs Authority (FDA) has issued an urgent public health alert following the circulation of falsified VISITECT CD4 Advanced Disease HIV test kits, cautioning that their use could compromise patient care and safety.
The regulator warns that the counterfeit kits may produce inaccurate results, potentially leading to misdiagnosis, delayed treatment, and serious health complications, particularly for vulnerable patients requiring timely intervention.
According to the FDA, the falsified products carry lot number 0001586 and wrongly identify Omega Diagnostics Limited of the United Kingdom as the manufacturer.
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In contrast, the genuine VISITECT CD4 Advanced Disease test kits are produced by AccuBio Limited, also based in the UK, under lot number 0002172 with distinct product specifications.
The authentic kits have a manufacturing date of July 2025 and expire in November 2026.
However, the counterfeit versions list August 2024 as the manufacturing date and January 2027 as the expiry date, raising further concerns about their safety and reliability in clinical use.
