Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Trichomonas Vaginalis test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Kit, Screening, TrichomonasDistribution: US Nationwide distribution.Recall #Z-0753-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Urinary Tract Infection Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Test, Urine LeukocyteDistribution: US Nationwide distribution.Recall #Z-0754-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Vaginal PH Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Dye-Indicator, Ph (Urinary, Non-Quantitative)Distribution: US Nationwide distribution.Recall #Z-0755-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Vitamin D-Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: System, Test, Vitamin DDistribution: US Nationwide distribution.Recall #Z-0756-2026
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-0757-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Environmental Pollutants Profile Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Enzyme Linked Immunoabsorbent Assay, CytomegalovirusDistribution: US Nationwide distribution.Recall #Z-0758-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Food Allergy Panel Test (IgE)
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: System, Test, Radioallergosorbent (Rast) ImmunologicalDistribution: US Nationwide distribution.Recall #Z-0759-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Food Sensitivity Test Large
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: System, Test, Radioallergosorbent (Rast) ImmunologicalDistribution: US Nationwide distribution.Recall #Z-0760-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Food Sensitivity Test Medium
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: System, Test, Radioallergosorbent (Rast) ImmunologicalDistribution: US Nationwide distribution.Recall #Z-0761-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Food Sensitivity Test Small
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: System, Test, Radioallergosorbent (Rast) ImmunologicalDistribution: US Nationwide distribution.Recall #Z-0762-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
GI Microbiome Profile Small
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemDistribution: US Nationwide distribution.Recall #Z-0763-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
GI Microbiome Profile XL
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemDistribution: US Nationwide distribution.Recall #Z-0764-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Mycotoxin Panel Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemDistribution: US Nationwide distribution.Recall #Z-0765-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
NAD Profile Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Nad Reduction/Nadh Oxidation, Cpk Or IsoenzymesDistribution: US Nationwide distribution.Recall #Z-0766-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Organic Acids Profile Test Large
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Dye-Indicator, Ph (Urinary, Non-Quantitative)Distribution: US Nationwide distribution.Recall #Z-0767-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Vitamin D2 and D3 Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: System, Test, Vitamin DDistribution: US Nationwide distribution.Recall #Z-0768-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Allergy Test IgE
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: System, Test, Radioallergosorbent (Rast) ImmunologicalDistribution: US Nationwide distribution.Recall #Z-0769-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Continuous Glucose Monitor (CGM)
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Integrated Continuous Glucose Monitoring System, Factory CalibratedDistribution: US Nationwide distribution.Recall #Z-0770-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Cholesterol Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Lipoprotein, High Density, Hdl, Over The CounterDistribution: US Nationwide distribution.Recall #Z-0771-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Adrenal Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Enzyme Immunoassay, Cortisol, SalivaryDistribution: US Nationwide distribution.Recall #Z-0772-2026