Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Illegally Marketed
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Enzyme Immunoassay, OpiatesDistribution: US Nationwide distribution.Recall #Z-0733-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Drug Test Small (4 substances)
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Enzyme Immunoassay, OpiatesDistribution: US Nationwide distribution.Recall #Z-0734-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Epstein-Barr Virus, OtherDistribution: US Nationwide distribution.Recall #Z-0735-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Fecal Occult Blood Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Reagent, Occult BloodDistribution: US Nationwide distribution.Recall #Z-0736-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Female Fertility Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Anti-Müllerian Hormone Test SystemDistribution: US Nationwide distribution.Recall #Z-0737-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Gonorrhea test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Kit, Identification, Neisseria GonorrhoeaeDistribution: US Nationwide distribution.Recall #Z-0738-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
H pylori (Peptic ulcer) Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Helicobacter PyloriDistribution: US Nationwide distribution.Recall #Z-0739-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Herpes (HSV-1 & HSV-2) Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Reagents, Specific, AnalyteDistribution: US Nationwide distribution.Recall #Z-0740-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
HPV Antigen Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Kit, Dna Detection, Human PapillomavirusDistribution: US Nationwide distribution.Recall #Z-0741-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Iron Deficiency Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Photometric Method, Iron (Non-Heme)Distribution: US Nationwide distribution.Recall #Z-0742-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Lyme Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Reagent, Borrelia Serological ReagentDistribution: US Nationwide distribution.Recall #Z-0743-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Menopause (FSH) 2 Tests
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Test, Follicle Stimulating Hormone (Fsh), Over The CounterDistribution: US Nationwide distribution.Recall #Z-0744-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
MPOX Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Immunohistochemistry Reagents And KitsDistribution: US Nationwide distribution.Recall #Z-0745-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Mycoplasma test, IgG and IgM
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Dna-Reagents, Mycoplasma Spp.Distribution: US Nationwide distribution.Recall #Z-0746-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Ovulation Test (5 tests)
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Test, Luteinizing Hormone (Lh), Over The CounterDistribution: US Nationwide distribution.Recall #Z-0747-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Parasite Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Giardia Spp.Distribution: US Nationwide distribution.Recall #Z-0748-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Pregnancy Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Kit, Test, Pregnancy, Hcg, Over The CounterDistribution: US Nationwide distribution.Recall #Z-0749-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Sperm Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Semen Analysis DeviceDistribution: US Nationwide distribution.Recall #Z-0750-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Syphilis Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Test, Syphilis, TreponemalDistribution: US Nationwide distribution.Recall #Z-0751-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Thyroid TSH Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Radioimmunoassay, Thyroid-Stimulating HormoneDistribution: US Nationwide distribution.Recall #Z-0752-2026