Class IIOngoingZ-0741-2026
GET TESTED INTERNATIONAL AB recalls HPV Antigen Test
Distribution without premarket approval/clearance.
- Human Papillomavirus Dna Detection Kit
- No Marketing Application
GET TESTED INTERNATION…Dec 10, 2025
Get Tested International AB recalls
The FDA has posted 92 enforcement recalls from Get Tested International AB since 2025, none of them Class I (most serious). Most recent report: Dec 10, 2025.
Class II: 92
Latest recalls
View all 92 in the recall browser →Class IIOngoingZ-0746-2026
GET TESTED INTERNATIONAL AB recalls Mycoplasma test
Distribution without premarket approval/clearance.
- Mycoplasma Spp. Dna-Reagents
- No Marketing Application
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0769-2026
GET TESTED INTERNATIONAL AB recalls Allergy Test IgE
Distribution without premarket approval/clearance.
- Radioallergosorbent (Rast) Immunological Test System
- No Marketing Application
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0733-2026
GET TESTED INTERNATIONAL AB recalls Illegally Marketed
Distribution without premarket approval/clearance.
- Opiates Enzyme Immunoassay
- No Marketing Application
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0793-2026
GET TESTED INTERNATIONAL AB recalls Parasite Test
Distribution without premarket approval/clearance.
- Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- No Marketing Application
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0767-2026
GET TESTED INTERNATIONAL AB recalls Organic Acids Profile Test Large
Distribution without premarket approval/clearance.
- Ph (Urinary, Non-Quantitative) Dye-Indicator
- No Marketing Application
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0750-2026
GET TESTED INTERNATIONAL AB recalls Sperm Test
Distribution without premarket approval/clearance.
- Semen Analysis Device
- No Marketing Application
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0756-2026
GET TESTED INTERNATIONAL AB recalls Vitamin D-Test
Distribution without premarket approval/clearance.
- Vitamin D Test System
- No Marketing Application
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0804-2026
GET TESTED INTERNATIONAL AB recalls Allergy test Small
Distribution without premarket approval/clearance.
- Salivary Cortisol Enzyme Immunoassay
- No Marketing Application
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0808-2026
GET TESTED INTERNATIONAL AB recalls Food Intolerance Test Small
Distribution without premarket approval/clearance.
- Radioallergosorbent (Rast) Immunological Test System
- No Marketing Application
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0775-2026
GET TESTED INTERNATIONAL AB recalls Candida Test
Distribution without premarket approval/clearance.
- Id Direct Antigen Candida Spp.
- No Marketing Application
GET TESTED INTERNATION…Dec 10, 2025
Class IIOngoingZ-0764-2026
GET TESTED INTERNATIONAL AB recalls GI Microbiome Profile XL
Distribution without premarket approval/clearance.
- Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- No Marketing Application
GET TESTED INTERNATION…Dec 10, 2025
Firm name as filed with the FDA: “GET TESTED INTERNATIONAL AB”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.