The Food and Drugs Authority has issued an urgent warning after uncovering counterfeit HIV testing kits circulating on the Ghanaian market, cautioning that their use could result in incorrect diagnoses and delays in treatment.

In a statement, the Authority identified the affected products as VISITECT CD4 Advanced Disease test kits with lot number 0001586. It explained that these falsified kits wrongly indicate Omega Diagnostics Limited as the manufacturer.

According to the regulator, authentic versions of the kits are produced by AccuBio Limited and carry a different lot number, 0002172, along with specific product details.

The FDA further noted inconsistencies in the production and expiry dates on the fake kits. While genuine kits were manufactured in July 2025 and are set to expire in November 2026, the counterfeit versions list August 2024 as the production date and January 2027 as the expiry date—clear indicators of irregularities.

The Authority stressed that such discrepancies should serve as warning signs for healthcare providers and users.

It warned that the presence of falsified medical products poses a serious threat, particularly in HIV care where precise testing is essential. Inaccurate results could delay treatment for infected individuals or cause undue distress for those who receive false-positive outcomes.

The FDA has therefore directed all health facilities, laboratories, and testing centres to immediately check their inventory and remove any kits bearing the affected lot number from use.

These products are to be returned to the nearest FDA office for proper disposal. The public and health professionals have also been urged to report any suspected counterfeit items through official channels.

The Authority added that investigations are ongoing to identify the source of the fake kits and hold those responsible accountable, while advising the public to verify all medical products before use.