The Food and Drugs Authority (FDA) has issued a public health alert following the discovery of falsified HIV diagnostic kits on the Ghanaian market.
The Authority warned that the circulation of these fake kits could lead to inaccurate test results, delayed treatment, and serious health consequences.
According to the FDA, the affected products are VISITECT CD4 Advanced Disease test kits with lot number 0001586. The Authority clarified that these kits are counterfeit and do not meet approved safety and quality standards.
It explained that the falsified products wrongly 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 information.
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The FDA highlighted inconsistencies in the manufacturing and expiry dates as a major red flag.
While authentic kits were manufactured in July 2025 and expire in November 2026, the counterfeit versions indicate August 2024 as the manufacturing date and January 2027 as the expiry date.
Health professionals have been urged to carefully verify such details before using any diagnostic kits.
The Authority stressed that the presence of fake HIV testing kits poses a significant threat to public health.
“Accurate testing is essential in HIV care, and any error can have major consequences,” the FDA cautioned.
It warned that incorrect results could delay treatment for individuals living with HIV or cause unnecessary distress for those who receive false-positive outcomes.
“Your health is too important to risk,” the Authority emphasised.
As part of urgent measures, the FDA has directed all hospitals, laboratories, and testing centres to inspect their stock of VISITECT CD4 test kits.
Any product bearing lot number 0001586 must be withdrawn from use immediately and returned to the nearest FDA office for proper disposal.
The FDA has encouraged healthcare professionals and the public to report any suspected counterfeit medical products through its official channels.
It also confirmed that investigations are underway to trace the source of the falsified kits and bring those responsible to justice.
The Authority is urging vigilance across the health sector and among the general public, stressing the importance of verifying medical products before use to avoid potentially life-threatening consequences.