The Food and Drugs Authority (FDA) has issued a public health alert after uncovering falsified HIV diagnostic kits being sold in Ghana, raising concerns about inaccurate test results and delays in treatment.
In a statement, the Authority identified the affected products as VISITECT CD4 Advanced Disease test kits bearing lot number 0001586, stressing that the items are counterfeit and fall below approved standards.
The FDA explained that the fake kits incorrectly list Omega Diagnostics Limited as the manufacturer, while authentic VISITECT CD4 test kits are produced by AccuBio Limited and carry a different lot number, 0002172, with verified product details.
It also highlighted discrepancies in the dates printed on the falsified products.
The counterfeit kits display inaccurate manufacturing and expiry dates, unlike the genuine versions, which were manufactured in July 2025 and are expected to expire in November 2026.
The fake kits, however, indicate August 2024 as the manufacturing date and January 2027 as the expiry date.
The Authority emphasised that such inconsistencies in manufacturer information and date markings should serve as red flags and urged healthcare providers to remain vigilant when handling medical products.
The FDA warned that the circulation of falsified HIV test kits poses a significant threat to public health, noting that accurate diagnosis is critical in HIV care.
Errors in testing could delay treatment for individuals living with HIV or create unnecessary anxiety for those who receive false-positive results.
“Your health is too important to risk,” the statement said, calling for heightened vigilance across the health sector.
As an immediate measure, the Authority has directed all hospitals, laboratories, and testing centres to inspect their stocks of VISITECT CD4 test kits and immediately withdraw any with lot number 0001586 from use.
It further instructed that the affected products be returned to the nearest FDA office for safe disposal.
The FDA also encouraged healthcare professionals and the public to report any suspected counterfeit medical products through its official channels.
Investigations have been launched to trace the source of the falsified kits and ensure those responsible are held accountable, while the public has been urged to verify medical products before use to avoid potential harm.
