FDA WARNING_LETTER - Genovate - January 08, 2026

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Genovate on January 8, 2026, following a review of the company"s website in January 2026. The letter addresses Genovate"s unauthorized marketing and distribution of a human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kit in the United States. The primary violation is that Genovate has offered its HIV DBS card self-collection kit for sale without required marketing authorization. Under the Federal Food, Drug, and Cosmetic Act, this product is considered an unapproved device, making it adulterated due to the absence of an approved premarket application or investigational device exemption. Furthermore, the kit is misbranded because Genovate failed to provide the necessary notification to the FDA before its commercial distribution. The FDA emphasizes a lack of assurance regarding the safety and effectiveness of the self-collection kit, citing concerns such as proper specimen collection, shipping integrity, and sample stability over time. Genovate is required to immediately cease all activities that cause the product to be unapproved and mislabeled. The company must promptly address all identified violations and provide a written response to the FDA within fifteen working days, detailing corrective actions taken, plans to prevent recurrence, and any supporting documentation.