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.

Mounjaro (tirzepatide) has emerged as one of the most impactful brands in the GLP‑1 category, showing remarkable traction over the last nine months. With growing acceptance among clinicians and increasing awareness among patients, Mounjaro’s performance reflects both strong clinical confidence and rising demand in the metabolic therapy space.