Class IIOngoingZ-0737-2026
GET TESTED INTERNATIONAL AB recalls Female Fertility Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Recalls: No Marketing Application
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 169–180 of 228 recalls
Class IIOngoingZ-0736-2026
GET TESTED INTERNATIONAL AB recalls Fecal Occult Blood Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0735-2026
GET TESTED INTERNATIONAL AB recalls Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0734-2026
GET TESTED INTERNATIONAL AB recalls Drug Test Small (4 substances)
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0733-2026
GET TESTED INTERNATIONAL AB recalls Illegally Marketed
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0732-2026
GET TESTED INTERNATIONAL AB recalls Diabetes HbA1c Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0731-2026
GET TESTED INTERNATIONAL AB recalls D-Dimer Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0730-2026
GET TESTED INTERNATIONAL AB recalls Chlamydia Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0729-2026
GET TESTED INTERNATIONAL AB recalls Candida Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0728-2026
GET TESTED INTERNATIONAL AB recalls Blood Type Test
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0727-2026
GET TESTED INTERNATIONAL AB recalls Alcohol (ALC) Test Saliva
Distribution without premarket approval/clearance.
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0534-2026
Quest International, Inc. recalls Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorban…
Due to distributing the measles IgG IVD without a premarket approved/cleared.
Quest International, I…FLNov 26, 2025