The Food and Drugs Authority (FDA) has issued a public health alert after discovering falsified HIV diagnostic kits being sold in Ghana, raising concerns about the risk of wrong 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. It explained that these kits are counterfeit and do not meet approved standards.
According to the FDA, the fake kits wrongly list Omega Diagnostics Limited as the manufacturer. In contrast, the genuine VISITECT CD4 test kits are produced by AccuBio Limited and carry a different lot number, 0002172, along with proper product details.
The Authority also pointed out clear inconsistencies in the dates printed on the products. It said the falsified kits show incorrect manufacturing and expiry dates.
While the original kits were manufactured in July 2025 and are due to expire in November 2026, the fake versions indicate August 2024 as the manufacturing date and January 2027 as the expiry date.
The FDA noted that such differences in manufacturer information and dates should serve as warning signs. It advised healthcare providers to pay close attention to these details when handling medical products.
The Authority said that the presence of falsified HIV test kits poses a serious threat to public health.
It noted that accurate testing is essential in HIV care, and that any error can have major consequences.
It said wrong results could delay treatment for people living with HIV or cause unnecessary fear for those who receive false-positive outcomes.
“Your health is too important to risk,” the FDA stated, calling for increased vigilance across the health sector.
As part of immediate measures, the Authority has directed all hospitals, laboratories, and testing centres to check their stock of VISITECT CD4 test kits. It warned that any kits with lot number 0001586 must be removed from use at once.
The FDA further instructed that such products should be returned to the nearest FDA office for proper disposal.
It also encouraged both health professionals and the public to report any suspected fake medical products through its official channels.
The Authority said it has begun investigations to trace the source of the falsified kits and ensure those responsible are held accountable. It also urged the public to verify medical products before use to avoid potential harm.
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