The Food and Drugs Authority has issued an urgent public health alert over the circulation of falsified VISITECT CD4 Advanced Disease HIV test kits, warning that their use could jeopardise patient care and safety.
The regulator cautioned that the counterfeit kits may deliver inaccurate results, potentially leading to misdiagnosis, delayed treatment, and serious health complications—particularly for patients who require timely intervention.
According to the FDA, the falsified products carry lot number 0001586 and falsely list Omega Diagnostics Limited of the United Kingdom as the manufacturer.
In contrast, genuine VISITECT CD4 Advanced Disease test kits are produced by AccuBio Limited under lot number 0002172, with distinct product specifications. The authentic kits have a manufacturing date of July 2025 and an expiry date of November 2026.
The counterfeit kits, however, incorrectly indicate August 2024 as the manufacturing date and January 2027 as the expiry date, raising further safety and reliability concerns in clinical use.
The FDA urges health facilities and professionals to verify test kits before use and report any suspicious products immediately to safeguard patients and maintain clinical integrity.
