Device recall: Alcohol (ALC) Test Saliva
GET TESTED INTERNATIONAL AB (Vastervik) initiated this device recall on 3 Nov 2025; FDA lists 92 product records under event 97896, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for GET TESTED INTERNATIONAL AB.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GET TESTED INTERNATIONAL AB, Vastervik, Sweden.
Reason for recall
"Distribution without premarket approval/clearance."
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0727-2026 | Alcohol (ALC) Test Saliva | 1 unit | Class II | Ongoing | 10 Dec 2025 |
| Z-0728-2026 | Blood Type Test | 47 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0729-2026 | Candida Test | 166 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0730-2026 | Chlamydia Test | 5 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0731-2026 | D-Dimer Test | 1218 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0732-2026 | Diabetes HbA1c Test | 148 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0733-2026 | Illegally Marketed | 1 unit | Class II | Ongoing | 10 Dec 2025 |
| Z-0734-2026 | Drug Test Small (4 substances) | 1 unit | Class II | Ongoing | 10 Dec 2025 |
| Z-0735-2026 | Epstein-Barr Virus (EBV VCA & EBNA IgG) Test | 4081 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0736-2026 | Fecal Occult Blood Test | 35 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0737-2026 | Female Fertility Test | 31 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0738-2026 | Gonorrhea test | 463 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0739-2026 | H pylori (Peptic ulcer) Test | 239 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0740-2026 | Herpes (HSV-1 & HSV-2) Test | 1361 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0741-2026 | HPV Antigen Test | 258 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0742-2026 | Iron Deficiency Test | 5187 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0743-2026 | Lyme Test | 940 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0744-2026 | Menopause (FSH) 2 Tests | 184 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0745-2026 | MPOX Test | 4 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0746-2026 | Mycoplasma test, IgG and IgM | 23 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0747-2026 | Ovulation Test (5 tests) | 128 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0748-2026 | Parasite Test | 658 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0749-2026 | Pregnancy Test | 2 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0750-2026 | Sperm Test | 33 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0751-2026 | Syphilis Test | 528 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0752-2026 | Thyroid TSH Test | 1916 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0753-2026 | Trichomonas Vaginalis test | 60 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0754-2026 | Urinary Tract Infection Test | 40 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0755-2026 | Vaginal PH Test | 31 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0756-2026 | Vitamin D-Test | 1557 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0757-2026 | Sperm Test | 1 unit | Class II | Ongoing | 10 Dec 2025 |
| Z-0758-2026 | Environmental Pollutants Profile Test | 1 unit | Class II | Ongoing | 10 Dec 2025 |
| Z-0759-2026 | Food Allergy Panel Test (IgE) | 3 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0760-2026 | Food Sensitivity Test Large | 3 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0761-2026 | Food Sensitivity Test Medium | 1 unit | Class II | Ongoing | 10 Dec 2025 |
| Z-0762-2026 | Food Sensitivity Test Small | 3 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0763-2026 | GI Microbiome Profile Small | 1 unit | Class II | Ongoing | 10 Dec 2025 |
| Z-0764-2026 | GI Microbiome Profile XL | 3 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0765-2026 | Mycotoxin Panel Test | 2 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0766-2026 | NAD Profile Test | 36 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0767-2026 | Organic Acids Profile Test Large | 1 unit | Class II | Ongoing | 10 Dec 2025 |
| Z-0768-2026 | Vitamin D2 and D3 Test | 10 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0769-2026 | Allergy Test IgE | 71 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0770-2026 | Continuous Glucose Monitor (CGM) | 4 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0771-2026 | Cholesterol Test | 80 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0772-2026 | Adrenal Test | 17 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0773-2026 | Akkermansia Test | 24 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0774-2026 | Biological Age & Longevity Test | 3 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0775-2026 | Candida Test | 109 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0776-2026 | DHEA Test | 17 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0777-2026 | Fructose Intolerance Test | 8 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0778-2026 | Gut Microbiome Test Large | 3 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0779-2026 | Gut Microbiome Test Medium | 3 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0780-2026 | Gut Microbiome Test Mega | 2 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0781-2026 | Gut Microbiome Test Small | 6 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0782-2026 | Gut Microbiome Test XL | 4 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0783-2026 | Hair Mineral Analysis | 19 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0784-2026 | IBS Test | 8 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0785-2026 | Intestinal Worms Test | 45 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0786-2026 | Lactose Intolerance Test | 15 units | Class II | Ongoing | 10 Dec 2025 |
Showing 60 of 92 product records; the FDA enforcement report lists all of them.
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Distribution without premarket approval/clearance."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.