Class IIOngoingZ-0741-2026
GET TESTED INTERNATIONAL AB recalls HPV Antigen Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–2 of 2 recalls
Distribution without premarket approval/clearance.
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.