The Recall Desk

Manufacturer

GET TESTED INTERNATIONAL AB

92 recalls in our database name GET TESTED INTERNATIONAL AB as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 92

  • HighFDA (Devices)·Z-0800-2026·2025-12-10

    Kidney Test Recalled for Distribution Without FDA Premarket Approval or Clearance

    GET TESTED INTERNATIONAL AB recalled its Kidney Test due to nationwide distribution without required FDA premarket approval or clearance. The device's safety and effectiveness were not established before distribution.

    Product
    Kidney Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0728-2026·2025-12-10

    Blood Type Test Recalled for Distribution Without FDA Approval

    GET TESTED INTERNATIONAL AB is recalling its Blood Type Test due to distribution without FDA premarket approval. Consumers who have purchased this product should not use it.

    Product
    Blood Type Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0732-2026·2025-12-10

    Unapproved Diabetes HbA1c Test Recalled for Distribution Without FDA Clearance

    GET TESTED INTERNATIONAL AB is recalling the Diabetes HbA1c Test (all lots) due to distribution without FDA premarket approval or clearance. Approximately 148 units were distributed nationwide.

    Product
    Diabetes HbA1c Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0759-2026·2025-12-10

    Food Allergy Panel Test Distributed Without FDA Premarket Clearance

    GET TESTED INTERNATIONAL AB has recalled Food Allergy Panel Test kits distributed nationwide because they were marketed without FDA premarket clearance. Consumers should stop using the test and consult their healthcare provider.

    Product
    Food Allergy Panel Test (IgE)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0808-2026·2025-12-10

    Food Intolerance Test Kit Recalled for Unapproved Distribution

    Food Intolerance Test Small by GET TESTED INTERNATIONAL AB was distributed nationwide without required FDA premarket approval or clearance.

    Product
    Food Intolerance Test Small
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0769-2026·2025-12-10

    Allergy Test IgE Distributed Without FDA Premarket Approval or Clearance

    GET TESTED INTERNATIONAL AB is recalling Allergy Test IgE devices distributed nationwide without FDA premarket approval or clearance. The devices were not validated before market distribution.

    Product
    Allergy Test IgE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2026·2025-12-10

    Organic Acids Profile Test Large Recalled for Unapproved Distribution

    GET TESTED INTERNATIONAL AB is recalling the Organic Acids Profile Test Large because it was distributed in the United States without FDA premarket approval or clearance. All lots are affected.

    Product
    Organic Acids Profile Test Large
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0756-2026·2025-12-10

    Vitamin D-Test Device Recalled for Distribution Without FDA Approval

    GET TESTED INTERNATIONAL AB is recalling Vitamin D-Test devices distributed without FDA premarket approval or clearance. The unapproved medical devices have not undergone FDA safety and efficacy review.

    Product
    Vitamin D-Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0729-2026·2025-12-10

    Candida Test Recalled for Distribution Without FDA Premarket Approval

    GET TESTED INTERNATIONAL AB is recalling the Candida Test due to distribution without FDA premarket approval or clearance. All 166 units distributed nationwide are affected.

    Product
    Candida Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0764-2026·2025-12-10

    GI Microbiome Profile XL Distributed Without FDA Premarket Approval

    GET TESTED INTERNATIONAL AB is recalling GI Microbiome Profile XL for distribution without FDA premarket approval or clearance. All lots were distributed nationwide in the United States.

    Product
    GI Microbiome Profile XL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0775-2026·2025-12-10

    Candida Test distributed without FDA premarket approval or clearance

    GET TESTED INTERNATIONAL AB recalled a Candida Test distributed nationwide without FDA premarket approval or clearance. Consumers should stop using the product and consult their healthcare provider.

    Product
    Candida Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2026·2025-12-10

    Parasite Test Recalled for Distribution Without FDA Premarket Approval

    GET TESTED INTERNATIONAL AB's Parasite Test is being recalled because it was distributed without required FDA premarket approval or clearance. All 94 units distributed nationwide should not be used.

    Product
    Parasite Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0727-2026·2025-12-10

    Saliva Alcohol Test Distributed Without FDA Premarket Approval

    Alcohol saliva test from GET TESTED INTERNATIONAL AB was distributed nationwide without FDA premarket approval or clearance. The device's safety and accuracy were never verified before market distribution.

    Product
    Alcohol (ALC) Test Saliva
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0754-2026·2025-12-10

    Urinary Tract Infection Test Recalled for Unapproved Distribution

    GET TESTED INTERNATIONAL AB recalled its Urinary Tract Infection Test because the device was distributed without FDA premarket approval or clearance. No illnesses have been reported.

    Product
    Urinary Tract Infection Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0786-2026·2025-12-10

    Lactose Intolerance Test Recalled for Distribution Without FDA Premarket Approval

    GET TESTED INTERNATIONAL AB is recalling the Lactose Intolerance Test due to distribution without FDA premarket clearance. The product was distributed nationwide without required regulatory approval.

    Product
    Lactose Intolerance Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0790-2026·2025-12-10

    Neurotransmitters Plus Distributed Without FDA Premarket Approval

    Neurotransmitters Plus was distributed nationwide without FDA premarket approval or clearance. Patients should consult their healthcare provider regarding this device.

    Product
    Neurotransmitters Plus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0818-2026·2025-12-10

    8 in 1 STI Test Kit distributed without FDA premarket approval

    GET TESTED INTERNATIONAL AB recalled its 8 in 1 STI Test Kit after distributing 2043 units nationwide without FDA premarket approval or clearance. The unapproved device poses a risk of unreliable or inaccurate test results.

    Product
    8 in 1 STI Test Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0773-2026·2025-12-10

    Akkermansia diagnostic test distributed without FDA premarket clearance

    Akkermansia Test, manufactured by GET TESTED INTERNATIONAL AB, was distributed nationwide without required FDA premarket approval. All lot numbers are affected.

    Product
    Akkermansia Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0750-2026·2025-12-10

    Sperm Test Distributed Without FDA Premarket Clearance

    A sperm test from GET TESTED INTERNATIONAL AB (33 units, nationwide US distribution) was recalled for being distributed without FDA premarket approval or clearance.

    Product
    Sperm Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2026·2025-12-10

    Allergy Test Small recalled for lacking FDA premarket approval

    Allergy Test Small was distributed without FDA premarket approval or clearance. Consumers should discontinue use and consult their healthcare provider for proper allergy testing.

    Product
    Allergy test Small
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0804-2026·2025-12-10

    Unapproved allergy test distributed without FDA clearance

    GET TESTED INTERNATIONAL AB distributed 76 units of its Allergy test Small product nationwide without FDA premarket approval or clearance.

    Product
    Allergy test Small
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2026·2025-12-10

    SIBO Test Recalled for Distribution Without FDA Premarket Approval

    GET TESTED INTERNATIONAL AB is recalling 55 units of the SIBO Test distributed nationwide in the US because the product was marketed without FDA premarket approval or clearance.

    Product
    SIBO Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0731-2026·2025-12-10

    D-Dimer Test Recalled for Distribution Without FDA Premarket Clearance

    GET TESTED INTERNATIONAL AB is recalling D-Dimer Test kits (1,218 units, all lots) distributed nationwide without FDA premarket approval. The unapproved test has not been reviewed by the FDA for safety and effectiveness.

    Product
    D-Dimer Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2026·2025-12-10

    GET TESTED Biological Age Test Recalled for Missing FDA Premarket Approval

    GET TESTED INTERNATIONAL AB is recalling its Biological Age & Longevity Test due to distribution without FDA premarket approval. This unapproved diagnostic was distributed nationwide.

    Product
    Biological Age & Longevity Test
    Category
    Medical Device
    Distribution
    Distributed nationwide