GET TESTED INTERNATIONAL AB

GET TESTED INTERNATIONAL AB: 92 FDA recall reports

Every medical device recall the FDA has published for GET TESTED INTERNATIONAL AB. The fault, and how the agency graded it.

92Reports
0Class I
92Ongoing
2025-12-10Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II92
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Food Intolerance Test Small

Z-0808-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Food Intolerance Test Small
Where it went
US Nationwide distribution.
How much
5 units

Vitamin D-Test

Z-0756-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Vitamin D-Test
Where it went
US Nationwide distribution.
How much
1557 units

Candida Test

Z-0775-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Candida Test
Where it went
US Nationwide distribution.
How much
109 units

Organic Acids Profile Test Large

Z-0767-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Organic Acids Profile Test Large
Where it went
US Nationwide distribution.
How much
1 unit

Allergy Test IgE

Z-0769-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Allergy Test IgE
Where it went
US Nationwide distribution.
How much
71 units

Allergy test Small

Z-0804-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Allergy test Small
Where it went
US Nationwide distribution.
How much
76 units

GI Microbiome Profile XL

Z-0764-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
GI Microbiome Profile XL
Where it went
US Nationwide distribution.
How much
3 units

Illegally Marketed

Z-0733-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Illegally Marketed
Where it went
US Nationwide distribution.
How much
1 unit

HPV Antigen Test

Z-0741-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
HPV Antigen Test
Where it went
US Nationwide distribution.
How much
258 units

Sperm Test

Z-0750-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Sperm Test
Where it went
US Nationwide distribution.
How much
33 units

Mycoplasma test, IgG and IgM

Z-0746-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Mycoplasma test, IgG and IgM
Where it went
US Nationwide distribution.
How much
23 units

Parasite Test

Z-0793-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Parasite Test
Where it went
US Nationwide distribution.
How much
94 units

Adrenal Test

Z-0772-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Adrenal Test
Where it went
US Nationwide distribution.
How much
17 units

Neurotransmitters Plus

Z-0790-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Neurotransmitters Plus
Where it went
US Nationwide distribution.
How much
18 units

Pollen Allergy Test

Z-0814-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Pollen Allergy Test
Where it went
US Nationwide distribution.
How much
10 units

Alcohol (ALC) Test Saliva

Z-0727-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Alcohol (ALC) Test Saliva
Where it went
US Nationwide distribution.
How much
1 unit

Gut Microbiome Test XL

Z-0782-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Gut Microbiome Test XL
Where it went
US Nationwide distribution.
How much
4 units

Pet Allergy Test

Z-0813-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Pet Allergy Test
Where it went
US Nationwide distribution.
How much
29 units

Urinary Tract Infection Test

Z-0754-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Urinary Tract Infection Test
Where it went
US Nationwide distribution.
How much
40 units

Lactose Intolerance Test

Z-0786-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Lactose Intolerance Test
Where it went
US Nationwide distribution.
How much
15 units

PSA Test

Z-0795-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
PSA Test
Where it went
US Nationwide distribution.
How much
27 units

Gut Microbiome Test Small

Z-0781-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Gut Microbiome Test Small
Where it went
US Nationwide distribution.
How much
6 units

8 in 1 STI Test Kit

Z-0818-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
8 in 1 STI Test Kit
Where it went
US Nationwide distribution.
How much
2043 units

Akkermansia Test

Z-0773-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Akkermansia Test
Where it went
US Nationwide distribution.
How much
24 units

Food Intolerance Test Medium

Z-0807-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Food Intolerance Test Medium
Where it went
US Nationwide distribution.
How much
16 units

Food Sensitivity Test Large

Z-0760-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Food Sensitivity Test Large
Where it went
US Nationwide distribution.
How much
3 units

Mycotoxin Panel Test

Z-0765-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Mycotoxin Panel Test
Where it went
US Nationwide distribution.
How much
2 units

Food Sensitivity Test Small

Z-0762-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Food Sensitivity Test Small
Where it went
US Nationwide distribution.
How much
3 units

Allergy test Small

Z-0803-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Allergy test Small
Where it went
US Nationwide distribution.
How much
19 units

Peptic Ulcer Test (H, pylori)

Z-0794-2026  ·  Class II  ·  reported 2025-12-10  ·  Ongoing

Why it was recalled
Distribution without premarket approval/clearance.
Product
Peptic Ulcer Test (H, pylori)
Where it went
US Nationwide distribution.
How much
12 units

Showing the 30 most recent of 92. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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