Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Akkermansia Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: General Purpose ReagentDistribution: US Nationwide distribution.Recall #Z-0773-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Biological Age & Longevity Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Plazomicin Test System, ImmunoassayDistribution: US Nationwide distribution.Recall #Z-0774-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Candida Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Candida Spp., Direct Antigen, IdDistribution: US Nationwide distribution.Recall #Z-0775-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
DHEA Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)Distribution: US Nationwide distribution.Recall #Z-0776-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Fructose Intolerance Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)Distribution: US Nationwide distribution.Recall #Z-0777-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Gut Microbiome Test Large
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical SamplesDistribution: US Nationwide distribution.Recall #Z-0778-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Gut Microbiome Test Medium
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical SamplesDistribution: US Nationwide distribution.Recall #Z-0779-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Gut Microbiome Test Mega
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical SamplesDistribution: US Nationwide distribution.Recall #Z-0780-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Gut Microbiome Test Small
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical SamplesDistribution: US Nationwide distribution.Recall #Z-0781-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Gut Microbiome Test XL
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical SamplesDistribution: US Nationwide distribution.Recall #Z-0782-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Hair Mineral Analysis
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical SamplesDistribution: US Nationwide distribution.Recall #Z-0783-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
IBS Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Calprotectin, FecalDistribution: US Nationwide distribution.Recall #Z-0784-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Intestinal Worms 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-0785-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Lactose 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-0786-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Leaky Gut Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Calprotectin, FecalDistribution: US Nationwide distribution.Recall #Z-0787-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Men s Hormone Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Radioimmunoassay, Testosterones And DihydrotestosteroneDistribution: US Nationwide distribution.Recall #Z-0788-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Neurotransmitters Basic
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Radioimmunoassay, ActhDistribution: US Nationwide distribution.Recall #Z-0789-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Neurotransmitters Plus
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Radioimmunoassay, ActhDistribution: US Nationwide distribution.Recall #Z-0790-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Neurotransmitters XL
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: Radioimmunoassay, ActhDistribution: US Nationwide distribution.Recall #Z-0791-2026
Open, ClassifiedPosted Dec 1, 2025·Initiated Nov 3, 2025
Organic acids Test
Reason: Distribution without premarket approval/clearance.
Root cause: No Marketing Application
Recalling firm: GET TESTED INTERNATIONAL ABType: System, Test, Urinary Methylmalonic AcidDistribution: US Nationwide distribution.Recall #Z-0792-2026