The Ghana Food and Drugs Authority (FDA) is warning the public over a falsified HIV diagnostic kit being sold on the market, raising concerns about the risk of wrong test results and delayed treatment.
In a public health alert issued by the Authority on Monday, April 6, 2026, it 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.
The Authority says the fake kits wrongly list Omega Diagnostics Limited as the manufacturer, in contrast with the genuine VISITECT CD4 test kits produced by AccuBio Limited with a different lot number, 0002172, along with proper product details.
Also, there are clear inconsistencies in the dates printed on the products, with the fake kits showing incorrect manufacturing and expiry dates.
According to the FDA, 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 Authority indicate that the difference in manufacturer information and dates should serve as warning signs to 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.
All hospitals, laboratories, and testing centres have been advised to check their stock of VISITECT CD4 test kits as part of immediate measures to curb the anomaly, warning 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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