
The Food and Drugs Authority has issued an urgent public health alert following the circulation of falsified VISITECT CD4 Advanced Disease HIV test kits, warning that their use could compromise patient care and safety.
According to the regulator, the counterfeit kits may generate inaccurate results, potentially leading to misdiagnosis, delayed treatment, and serious health complications, particularly for vulnerable patients who require timely medical intervention.
The FDA stated that the falsified products carry lot number 0001586 and incorrectly list Omega Diagnostics Limited as the manufacturer.
In contrast, the authentic VISITECT CD4 Advanced Disease test kits are produced by AccuBio Limited under lot number 0002172, with clearly distinct product specifications.
The genuine kits have a manufacturing date of July 2025 and an expiry date of November 2026. However, the counterfeit versions reportedly indicate August 2024 as the manufacturing date and January 2027 as the expiry date, raising further concerns about their safety and reliability in clinical use.
The FDA is urging healthcare providers, pharmacies, hospitals, and the general public to remain vigilant and verify product details before use. The authority emphasized that the use of falsified diagnostic kits poses a significant risk to public health and could undermine efforts in HIV care and treatment.
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