FDA alerts public about fake HIV test kits on the market

The Food and Drugs Authority has warned of falsified HIV test kits in circulation, urging healthcare providers and the public to check products carefully to avoid misdiagnosis and serious health risks.

In a statement on its X page on April 2, 2026, it said the fake products pose a serious threat to public health, particularly in HIV care, where accurate testing is critical.

The regulator identified the counterfeit products as VISITECT CD4 Advanced Disease test kits bearing lot number 0001586.

It said the falsified kits incorrectly list Omega Diagnostics Limited as the manufacturer.

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However, the genuine kits are produced by AccuBio Limited and carry a different lot number, 0002172, along with distinct product specifications.

According to the FDA, the fake kits 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.

“The falsified kits bear the VISITECT brand and are labelled for "CD4 Advanced Disease" testing. According to the alert, the affected products display the following information: Lot Number: 0001586 IFU Version: 3 Manufacturing Date: 2024-08

“Expiry Date: 2027-01. The packaging lists Omega Diagnostics LTD of the United Kingdom as the manufacturer, complete with the company's address in Alva FK12 5DD, and telephone number. However, a red flag notice printed on the alert states: "Manufacturer is DIFFERENT!" – indicating that the true source of the falsified kits is not Omega Diagnostics,” it said.

It said all affected kits should be returned to the nearest FDA office for safe disposal.

The FDA also urged health professionals and the public to report suspected falsified products through official channels.

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