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.

26–50 of 92

  • HighFDA (Devices)·Z-0805-2026·2025-12-10

    Estrogen & Progesterone Test Distributed Without FDA Premarket Clearance

    GET TESTED INTERNATIONAL AB distributed an Estrogen & Progesterone Test without FDA premarket approval. All lots were distributed nationwide, and consumers should not use this unapproved medical device.

    Product
    Estrogen & Progesterone Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0770-2026·2025-12-10

    Continuous Glucose Monitor Recalled for Distribution Without FDA Clearance

    GET TESTED INTERNATIONAL AB is recalling the Continuous Glucose Monitor because it was distributed in the United States without FDA premarket clearance. Patients should consult their healthcare provider.

    Product
    Continuous Glucose Monitor (CGM)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2026·2025-12-10

    Pollen Allergy Test Recalled for Distribution Without FDA Premarket Approval

    GET TESTED INTERNATIONAL AB's Pollen Allergy Test was distributed nationwide without FDA premarket approval or clearance. Consumers should discontinue use and consult their healthcare provider.

    Product
    Pollen Allergy Test
    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-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-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-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-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
  • 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-0738-2026·2025-12-10

    Gonorrhea test recalled for distribution without FDA premarket approval

    The FDA is recalling a gonorrhea test that was distributed without required premarket approval and clearance. GET TESTED INTERNATIONAL AB must immediately cease distribution.

    Product
    Gonorrhea test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2026·2025-12-10

    Thyroid TSH Test Recalled for Distribution Without FDA Approval

    GET TESTED INTERNATIONAL AB recalled its Thyroid TSH Test (1916 units, US nationwide) because it was distributed without FDA premarket approval or clearance required for this Class II medical device.

    Product
    Thyroid TSH Test
    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-0801-2026·2025-12-10

    Unapproved Liver Test Distributed Without FDA Premarket Clearance

    GET TESTED INTERNATIONAL AB's Liver Test was distributed nationwide without FDA premarket approval or clearance. All lots are being recalled due to unapproved distribution.

    Product
    Liver Test
    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-0739-2026·2025-12-10

    H. pylori diagnostic test recalled for distribution without FDA approval

    GET TESTED INTERNATIONAL AB is recalling its H. pylori (Peptic Ulcer) Test distributed in the US because it was distributed without FDA premarket approval or clearance. The test was not verified for safety and effectiveness by the FDA before distribution.

    Product
    H pylori (Peptic ulcer) Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0789-2026·2025-12-10

    Neurotransmitters Basic Medical Device Recalled for Lack of FDA Clearance

    GET TESTED INTERNATIONAL AB is recalling the Neurotransmitters Basic medical device for distribution without FDA premarket approval. The device was marketed nationwide without required regulatory clearance.

    Product
    Neurotransmitters Basic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0735-2026·2025-12-10

    Epstein-Barr Virus Test Recalled for Distribution Without FDA Approval

    GET TESTED INTERNATIONAL AB is recalling 4,081 units of an Epstein-Barr Virus test that was distributed nationwide without FDA premarket approval. The recall affects all lots of this diagnostic test.

    Product
    Epstein-Barr Virus (EBV VCA & EBNA IgG) Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2026·2025-12-10

    Neurotransmitters XL Medical Device Recalled for Unapproved Distribution

    GET TESTED INTERNATIONAL AB is recalling Neurotransmitters XL devices nationwide due to distribution without FDA premarket approval or clearance. Consumers should discontinue use.

    Product
    Neurotransmitters XL
    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-0755-2026·2025-12-10

    Vaginal pH test recalled for distribution without FDA premarket clearance

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

    Product
    Vaginal PH Test
    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-0760-2026·2025-12-10

    Food Sensitivity Test Recalled Nationwide for Unapproved Distribution

    GET TESTED INTERNATIONAL AB is recalling its Food Sensitivity Test Large due to distribution without premarket FDA approval. The product was distributed nationwide without FDA clearance for safety and effectiveness.

    Product
    Food Sensitivity Test Large
    Category
    Medical Device
    Distribution
    Distributed nationwide