FDA warns of fake HIV test kits on Ghanaian market

The Food and Drugs Authority (FDA) has issued an urgent public health alert following the discovery of falsified HIV diagnostic kits circulating in Ghana, warning of the potential risk of inaccurate test results and delayed treatment.

In an official statement, the Authority identified the affected products as VISITECT CD4 Advanced Disease test kits bearing lot number 0001586. According to the FDA, these kits are counterfeit and fail to meet the required safety and quality standards approved for medical diagnostics.

The FDA explained that the falsified kits incorrectly list Omega Diagnostics Limited as the manufacturer. However, genuine VISITECT CD4 test kits are produced by AccuBio Limited and carry a different lot number—0002172—along with accurate product labeling and certification details.

Further discrepancies were identified in the manufacturing and expiry dates printed on the products. The authentic kits were manufactured in July 2025 and are expected to expire in November 2026. In contrast, the counterfeit versions falsely indicate a manufacturing date of August 2024 and an expiry date of January 2027.

The Authority stressed that such inconsistencies in manufacturer information, batch numbers, and dates should serve as clear warning signs for healthcare providers and distributors. It urged medical professionals to exercise heightened vigilance when handling and verifying diagnostic products.

The FDA warned that the presence of falsified HIV testing kits poses a serious threat to public health, given the critical role of accurate diagnosis in HIV care and management. Incorrect results could lead to delayed treatment for individuals living with HIV or cause unnecessary psychological distress for those who receive false-positive outcomes.

“Your health is too important to risk,” the Authority stated, emphasizing the need for strict adherence to safety protocols across the healthcare system.

As part of immediate response measures, the FDA has directed all hospitals, laboratories, and testing centres nationwide to inspect their stock of VISITECT CD4 test kits. Any kits bearing lot number 0001586 are to be withdrawn from use immediately.

The Authority further instructed that all suspected counterfeit products should be returned to the nearest FDA office for proper disposal in accordance with regulatory procedures.

Additionally, healthcare professionals and members of the public are encouraged to report any suspected falsified or substandard medical products through the FDA’s official reporting channels.

The FDA confirmed that investigations are currently underway to trace the origin and distribution network of the counterfeit kits, with the aim of identifying and prosecuting those responsible. It also reiterated the importance of verifying the authenticity of medical products before use to prevent harm and safeguard public health.