The Food and Drugs Authority (FDA) has issued a public health alert following the discovery of falsified HIV diagnostic kits on the Ghanaian market, warning of the risk of inaccurate test results and delayed treatment.
In a statement, the Authority identified the affected products as VISITECT CD4 Advanced Disease test kits with lot number 0001586, stressing that the kits are counterfeit and do not meet approved safety and quality standards.
It explained that while the fake products list Omega Diagnostics Limited as the manufacturer, genuine VISITECT CD4 kits are produced by AccuBio Limited and carry a different lot number—0002172—along with accurate product details.
The FDA further highlighted discrepancies in the manufacturing and expiry dates as key warning signs.
According to the Authority, authentic kits were manufactured in July 2025 and are expected to expire in November 2026, whereas the falsified versions indicate August 2024 as the manufacturing date and January 2027 as the expiry date.
It urged healthcare providers to carefully verify such details when handling medical supplies.
Describing the development as a serious public health threat, the Authority stressed that accurate HIV testing is critical to effective care, noting that incorrect results could either delay treatment for infected persons or cause unnecessary anxiety for those who receive false-positive outcomes.
As an immediate measure, the FDA has directed all hospitals, laboratories, and testing centres to inspect their stocks and withdraw any VISITECT CD4 kits bearing the affected lot number.
It further instructed that such products be returned to the nearest FDA office for safe disposal.
The Authority also encouraged health professionals and the public to report suspected falsified medical products through its official channels, adding that investigations are underway to trace the source of the counterfeit kits and bring those responsible to justice.
