The Food and Drugs Authority (FDA) has raised a red flag over counterfeit HIV test kits being sold across the country, warning that they could give wrong results and put lives at risk.
The affected product is the VISITECT CD4 Advanced Disease test kit with lot number 0001586. These fake kits falsely claim to be made by Omega Diagnostics Limited. The real ones come from AccuBio Limited, carry lot number 0002172, and have completely different markings.One of the easiest ways to spot the fakes is the dates printed on the box.
Genuine kits were manufactured in July 2025 and will expire in November 2026. The counterfeit versions wrongly show August 2024 as the manufacturing date and January 2027 as the expiry date.The FDA says these differences are clear warning signs for hospitals, laboratories and testing centres.
Using the fake kits could lead to serious mistakes — either delaying life-saving treatment for people who actually have HIV, or causing healthy people to receive frightening false-positive results.“Your health is too important to risk,” the Authority stressed in its alert.
All health facilities have been ordered to immediately check their stocks and pull any kits with lot number 0001586 out of use right away.
The fake products must be returned to the nearest FDA office for safe disposal.The FDA has launched an investigation to trace where the counterfeit kits came from and who is behind them.
In the meantime, it is urging both health workers and ordinary Ghanaians to stay alert and report any suspicious medical products through official channels.
Accurate HIV testing is critical for controlling the virus and protecting public health. Health officials say anyone who recently used a VISITECT CD4 kit and has concerns should contact their healthcare provider or the FDA for guidance.