FDA warns of fake HIV test kits in Ghana, urges immediate checks by health facilities

The Food and Drugs Authority has issued an urgent public health alert following the discovery of falsified HIV diagnostic kits on the Ghanaian market, warning that their use could lead to dangerous misdiagnosis and delayed treatment.

In a statement, the regulator identified the counterfeit products as VISITECT CD4 Advanced Disease test kits bearing lot number 0001586. The falsified kits incorrectly list Omega Diagnostics Limited as the manufacturer. However, the genuine kits are produced by AccuBio Limited and carry a different lot number, 0002172, along with distinct product specifications.

The FDA cautioned that the fake kits also display incorrect manufacturing and expiry dates. While authentic kits were manufactured in July 2025 and expire in November 2026, the falsified versions list August 2024 as the manufacturing date and January 2027 as the expiry date.

According to the authority, discrepancies in manufacturer details and dates are key warning signs that should immediately raise suspicion among healthcare providers and users.

Serious Public Health Risk

The FDA warned that falsified medical products pose a significant threat to public health, particularly in HIV care where accurate testing is critical. Incorrect results from such kits could lead to delayed treatment for individuals living with HIV or unnecessary anxiety for those who receive false-positive results. In both cases, the consequences can be severe and life-altering.

“Your health is too important to risk,” the authority stated, urging strict vigilance across the healthcare system.

The FDA has directed all hospitals, laboratories and testing centres to immediately inspect their stocks of VISITECT CD4 test kits. Any product bearing lot number 0001586 must be withdrawn from use without delay.

Affected kits are to be returned to the nearest FDA office for safe disposal. Health professionals and the public have also been encouraged to report suspected falsified products through official FDA contact lines. The FDA said investigations are underway to trace the source of the falsified HIV test kits and bring those responsible to justice, while urging the public to verify all medical products before use.

Source: 3news.com