The FDA has posted 5 enforcement recalls of gastrointestinal pathogen panel multiplex nucleic acid-based assay system devices since 2025, none of them Class I (most serious). Most recent report: Dec 10, 2025.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Distribution without premarket approval/clearance.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System”). Informational only — verify against the FDA before acting.