CLASS II ONGOING Device recall · Reported 10 Dec 2025 · FDA Enforcement Report

Fructose Intolerance Test recalled by Get Tested International Ab

GET Tested International AB is recalling Fructose Intolerance Test, distributed nationwide in the US. The recall was initiated on 3 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesEAN: 616612787323; SKU: 2B120; UDI-DI: None; Lot/Serial Number: All Lots;

Quantity recalled8 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0777-2026
FDA event ID: 97896
Recalling firm: GET Tested International AB, Vastervik
Classification: Class II
Status: Ongoing
Recall initiated: 3 Nov 2025
FDA classified: 1 Dec 2025
Reported: 10 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Nov 2025	Recall initiated by company
1 Dec 2025	Classified by FDA	+28 days
10 Dec 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Distribution without premarket approval/clearance.

Product as listed by the FDA

Fructose Intolerance Test

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Distribution without premarket approval/clearance.

Which lots are affected?

EAN: 616612787323; SKU: 2B120; UDI-DI: None; Lot/Serial Number: All Lots;

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

91 other products · FDA event 97896

This product is part of a recall event; the main page for the event is Food Intolerance Test Small recalled by Get Tested International Ab.

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025	CLASS II	Food Intolerance Test Small recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Vitamin D-Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Candida Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Organic Acids Profile Test Large recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Allergy Test IgE recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Allergy test Small recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	GI Microbiome Profile XL recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Illegally Marketed recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	HPV Antigen Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Sperm Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Mycoplasma test, IgG and IgM recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Parasite Test recalled by Get Tested International Ab	GET Tested International AB	Cyclospora	Nationwide
10 Dec 2025	CLASS II	Adrenal Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Neurotransmitters Plus recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Pollen Allergy Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Alcohol (ALC) Test Saliva recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Gut Microbiome Test XL recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Pet Allergy Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Urinary Tract Infection Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Lactose Intolerance Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	PSA Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Gut Microbiome Test Small recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	1 STI Test Kit recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Akkermansia Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Food Intolerance Test Medium recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Food Sensitivity Test Large recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Mycotoxin Panel Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Food Sensitivity Test Small recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Allergy test Small recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Peptic Ulcer Test (H, pylori) recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Heavy Metals Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Trichomonas Vaginalis test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	SIBO Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Intestinal Worms Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	D-Dimer Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Diabetes HbA1c Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Candida Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Syphilis Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Iodine Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	MPOX Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	GI Microbiome Profile Small recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Parasite Test recalled by Get Tested International Ab	GET Tested International AB	Cyclospora	Nationwide
10 Dec 2025	CLASS II	Sperm Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	DHEA Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Serotonin Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Female Fertility Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Gut Microbiome Test Mega recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Food Allergy Panel Test (IgE) recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Food Intolerance Test Large recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	NAD Profile Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Vitamin D2 and D3 Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Leaky Gut Test recalled by Get Tested International Ab	GET Tested International AB	Packaging Defects	Nationwide
10 Dec 2025	CLASS II	Kidney Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	1 Trichomonas / Gardnerella Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Menopause (FSH) 2 Tests recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Blood Type Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	1 STI Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Biological Age & Longevity Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Lyme Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Drug Test Small (4 substances) recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Organic acids Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Hair Mineral Analysis recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Gut Microbiome Test Large recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Chlamydia Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Gonorrhea test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Cholesterol Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Iron Deficiency Test (ferritin) recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Thyroid TSH Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Herpes (Hsv-1 & Hsv-2) Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Iron Deficiency Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Diabetes Test (ketones & glucose) recalled	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Liver Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Pregnancy Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Allergy & Food Intolerance Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Ovulation Test (5 tests) recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Food Sensitivity Test Medium recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Men s Hormone Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	H pylori (Peptic ulcer) Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Neurotransmitters Basic recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Epstein-Barr Virus (EBV VCA & EBNA IgG) Test recalled	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Fecal Occult Blood Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Women s Hormone Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Melatonin Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Neurotransmitters XL recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	IBS Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Sorbitol Intolerance Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Environmental Pollutants Profile Test recalled	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Vaginal PH Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Gut Microbiome Test Medium recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Estrogen & Progesterone Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025	CLASS II	Continuous Glucose Monitor (CGM) recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide

More recalls from GET Tested International AB

All 92

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Device	CLASS II	Continuous Glucose Monitor (CGM) recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025Device	CLASS II	Estrogen & Progesterone Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025Device	CLASS II	Gut Microbiome Test Medium recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025Device	CLASS II	Vaginal PH Test recalled by Get Tested International Ab	GET Tested International AB	Other	Nationwide
10 Dec 2025Device	CLASS II	Environmental Pollutants Profile Test recalled	GET Tested International AB	Other	Nationwide

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