The Ghana Food and Drugs Authority (FDA) has issued a critical public health alert warning healthcare providers and the public about falsified VISITECT CD4 test kits currently circulating in the country.
Released on April 6, 2026, the notice highlights serious risks associated with these counterfeit products, which could lead to inaccurate CD4 count results and potentially compromise HIV patient care across Ghana.
Details of Falsified VISITECT CD4 Test Kits Circulating in Ghana
According to the FDA, the falsified VISITECT CD4 Advanced Disease HIV test kits bear lot number 0001586 and incorrectly list Omega Diagnostics Limited (UK) as the manufacturer. These fake kits display an August 2024 manufacturing date and a January 2027 expiry, raising immediate red flags for quality and authenticity issues that could affect diagnostic accuracy in HIV management.
How to Identify Authentic VISITECT CD4 Test Kits from Ghana FDA Alert
In contrast, genuine VISITECT CD4 test kits are manufactured by AccuBio Limited (UK) under lot number 0002172. These authentic versions were produced in July 2025 and carry a November 2026 expiry date. The FDA strongly advises all users, including laboratories and clinics, to carefully verify lot numbers, manufacturer details, and expiry information on every kit before use to avoid any reliance on compromised testing supplies.
Health facilities and individuals are urged to stop using any suspicious kits immediately and report them to the Ghana FDA for further investigation. This proactive step helps safeguard public health and ensures continued trust in HIV diagnostic tools nationwide, especially as accurate CD4 testing remains vital for monitoring advanced HIV disease and guiding treatment decisions.
For ongoing updates on medical device safety and regulatory alerts in Ghana, visit our dedicated resource page on [FDA-approved health products](/fda-approved-health-products-ghana). The authority continues to monitor the situation closely to prevent any further distribution of these falsified VISITECT CD4 HIV test kits.
