BY Nadia Ntiamoah
The Food and Drugs Authority (FDA) has issued an urgent public health alert over the circulation of falsified VISITECT CD4 Advanced Disease HIV test kits, warning that their use could pose serious risks to patient safety and treatment outcomes.
According to the regulator, the counterfeit test kits are capable of producing inaccurate results, which could lead to misdiagnosis, delayed treatment, and potentially life-threatening complications—especially for patients who require timely medical intervention.
The FDA disclosed that the falsified products are identified with lot number 0001586 and incorrectly list Omega Diagnostics Limited as the manufacturer.
However, investigations have confirmed that the genuine VISITECT CD4 Advanced Disease test kits are produced by AccuBio Limited.
Authorities further explained that authentic kits bear lot number 0002172, with a manufacturing date of July 2025 and an expiry date of November 2026.
In contrast, the counterfeit versions display inconsistent product details, including a manufacturing date of August 2024 and an expiry date of January 2027—raising significant concerns about their authenticity and reliability.
The VISITECT CD4 test kits are critical tools used in assessing immune system function in people living with HIV, helping clinicians determine the severity of the disease and guide appropriate treatment decisions. Any compromise in their accuracy, the FDA warns, could have far-reaching consequences for patient care.
The Authority is therefore urging healthcare providers, pharmacies, and the general public to remain vigilant and avoid the use or distribution of the suspected counterfeit products.
It also called on stakeholders to report any sightings of the falsified kits to regulatory authorities for immediate action.
