The U.S. Food and Drug Administration (FDA) has issued an official warning letter to Genetrace, a company based in Blaine, Washington, for offering an HIV diagnostic self-collection kit to U.S. customers without proper authorization.
According to the FDA, the product in question is a dried blood spot (DBS) card self-collection kit that people use at home to collect blood samples and send them to a lab for HIV testing. The agency says this kit qualifies as a medical device because it is meant to help diagnose disease.
However, Genetrace did not have FDA approval, such as a required premarket approval (PMA) or an investigational device exemption (IDE). The FDA also noted that the company failed to notify the agency before selling the device, which is required by law. Because of these issues, the FDA called the product “adulterated” and “misbranded” under U.S. law.
The letter reminds Genetrace that no HIV self-collection kit from the company is authorized for use in diagnosing HIV. Without proper approval, the safety and accuracy of the device cannot be assured.
The FDA gave Genetrace a chance to fix the problems but ordered the company to stop selling or distributing the kit that violates the law. If Genetrace does not address the issues quickly, the FDA warned it could take stronger actions, such as seizures, fines, or legal injunctions.
The agency also pointed out that FDA-approved over-the-counter HIV tests already exist for at-home use, which consumers can rely on instead.
