FDA WARNING_LETTER - ProDx Health - January 01, 2026

On January 8, 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to ProDx Health after a review of its website in January 2026 revealed the company was offering a Human Immunodeficiency Virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kit for sale without required marketing authorization. Under the Federal Food, Drug, and Cosmetic Act, this kit is classified as a medical device. However, it was deemed adulterated due to the absence of an approved premarket approval application (PMA) or an investigational device exemption (IDE). Additionally, the device was misbranded because ProDx Health failed to provide the necessary 510(k) notification to the agency before introducing it into commercial distribution. The FDA highlighted a lack of assurance regarding the kit"s safety and effectiveness, raising concerns about proper self-collection techniques, sample shipping integrity, and specimen stability over time. ProDx Health is required to immediately cease all activities resulting in the misbranding or adulteration of its HIV DBS card self-collection kit. The company must provide a written response to the FDA within fifteen working days, detailing specific corrective actions taken, explaining how these violations will be prevented from recurring, and submitting supporting documentation. Failure to address these deficiencies may lead to further regulatory action.