Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GET TESTED INTERNATIONAL
- Product type
- Gut Microbiome Test Large
- Model numbers
- EAN: 616612785893, SKU: A130
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Distribution without premarket approval/clearance.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter
About This Product
This is a gut microbiome test kit intended to analyze stool samples to profile gut bacteria and inform health-related decisions.
Why This Is Dangerous
The recall concerns distribution without FDA premarket approval or clearance, a regulatory deficiency affecting oversight and reliability of the product.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Limited to 3 units in the U.S. The lack of clearance could cast doubt on test results and patient guidance.
Practical Guidance
How to identify if yours is affected
- 1. Verify the kit you have is Gut Microbiome Test Large from GET TESTED INTERNATIONAL AB.
- 2. Check for EAN 616612785893 or SKU A130.
- 3. Confirm Lot/Serial Number: All Lots.
Where to find product info
FDA enforcement report Z-0778-2026 on FDA.gov and the manufacturer recall notice.
What timeline to expect
Recall remedies and refunds are not specified in the notice.
If the manufacturer is unresponsive
- File a complaint with the FDA if the company does not respond within 8 weeks.
- Consult a health care provider if you have concerns about test results or health decisions.
How to prevent similar issues
- Only purchase diagnostics from reputable, FDA-cleared sources.
- Verify regulatory status before marketing or using any medical test kit.
- Ask for the device's clearance or approval documentation before purchase.
Documentation advice
Keep the recall letter, all communications with the company, and photos of the product and identifiers.
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Product Details
Model numbers and identifiers: EAN 616612785893; SKU A130; UDI-DI: None; Lot/Serial Number: All Lots. Distribution: US nationwide. Quantity: 3 units. Sold by: GET TESTED INTERNATIONAL (brand standardized). Recall date: 2025-11-03. Report date: 2025-12-10. Status: ACTIVE. Category: Health & Personal Care, Medical Devices.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution
- Model A130, EAN 616612785893
- Lot/Serial Number: All Lots
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