FDA WARNING_LETTER - ProDx Health - February 02, 2026

The FDA issued a Warning Letter to ProDx Health on February 10, 2026, addressed to CEO Dr. Andreas Kogelnik, following a review of the company’s website (last visited February 2026) and a February 3, 2026, company response. The letter, from the Center for Biologics Evaluation and Research (CBER), cited significant violations concerning the firm’s human immunodeficiency virus (HIV) serological diagnostic sample self-collection kits. The primary issue is that ProDx Health is offering these kits for sale without required marketing authorization, in contravention of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the devices are deemed adulterated under section 501(f)(1)(B) because they lack an approved premarket approval application (PMA) or an investigational device exemption (IDE). Furthermore, the kits are misbranded under section 502(o) as the company failed to provide required notification of intent to introduce the devices into commercial distribution (510(k)). These violations raise serious safety and effectiveness concerns, particularly regarding self-collection process, sample integrity during shipping, and stability. ProDx Health is required to immediately cease all activities leading to the misbranding or adulteration of its sample self-collection kits. The company must take prompt corrective action and respond to the FDA in writing within fifteen working days, detailing the steps taken to correct violations and prevent recurrence. Failure to comply may result in further regulatory actions, including seizure or injunction.