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: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay SystemDistribution: US Nationwide distribution.Recall #Z-0793-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Peptic Ulcer Test (H, pylori)
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Helicobacter PyloriDistribution: US Nationwide distribution.Recall #Z-0794-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
PSA Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Prostate-Specific Antigen (Psa) For Management Of Prostate CancersDistribution: US Nationwide distribution.Recall #Z-0795-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
SIBO Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: System, Breath MeasurementDistribution: US Nationwide distribution.Recall #Z-0796-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Sorbitol Intolerance Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: System, Breath MeasurementDistribution: US Nationwide distribution.Recall #Z-0797-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Women s Hormone 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-0798-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Diabetes Test (ketones & glucose)
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Method, Enzymatic, Glucose (Urinary, Non-Quantitative)Distribution: US Nationwide distribution.Recall #Z-0799-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Kidney Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Prognostic Test For Assessment Of Chronic Kidney Disease ProgressionDistribution: US Nationwide distribution.Recall #Z-0800-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Liver Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Prognostic Test For Assessment Of Chronic Kidney Disease ProgressionDistribution: US Nationwide distribution.Recall #Z-0801-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Allergy & Food Intolerance Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Prognostic Test For Assessment Of Chronic Kidney Disease ProgressionDistribution: US Nationwide distribution.Recall #Z-0802-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Allergy 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-0803-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Allergy test Small
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-0804-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Estrogen & Progesterone Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Radioimmunoassay, Total Estrogens In PregnancyDistribution: US Nationwide distribution.Recall #Z-0805-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Food Intolerance 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-0806-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Food Intolerance 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-0807-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Food Intolerance 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-0808-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Heavy Metals Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Radioimmunoassay (Two-Site Solid Phase), FerritinDistribution: US Nationwide distribution.Recall #Z-0809-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Iodine Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Wet Ash Method, Protein-Bound IodineDistribution: US Nationwide distribution.Recall #Z-0810-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Iron Deficiency Test (ferritin)
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Agent, Absorbable Hemostatic, Non-Collagen BasedDistribution: US Nationwide distribution.Recall #Z-0811-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Melatonin Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Agent, Absorbable Hemostatic, Non-Collagen BasedDistribution: US Nationwide distribution.Recall #Z-0812-2026