FDA WARNING_LETTER - Genetrace - January 08, 2026

The FDA issued a Warning Letter to Genetrace on January 8, 2026, regarding the unlawful sale of its human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kit. The agency found that Genetrace offered this medical device for sale without obtaining the necessary marketing authorization, violating the Federal Food, Drug, and Cosmetic Act.

Specifically, the kit was deemed adulterated because it lacked an approved premarket approval application or an investigational device exemption. It was also misbranded as Genetrace failed to provide the required notification of its intent to introduce the device into commercial distribution. The FDA expressed concerns about the lack of assurance regarding the kit"s safety and effectiveness, including issues related to proper self-collection, sample shipping, and specimen stability, noting a previous communication to Genetrace in March 2025 regarding these apparent violations.

Genetrace is required to immediately cease all activities that result 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, outlining the specific steps taken to correct these violations and detailing measures to prevent their recurrence. Failure to comply may lead to further regulatory actions.