Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- Get Tested International AB
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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 AB
- Product type
- In Vitro Diagnostic Test Kit
- Model numbers
- EAN: 616612785923, SKU: A500, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Multiple Retailers
- 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
The Leaky Gut Test is marketed as a diagnostic device to assess gut permeability. It is distributed in the United States and is intended for patient use or clinician use.
Why This Is Dangerous
The hazard arises from distribution without FDA premarket approval or clearance. Without FDA authorization, the device may not meet safety and effectiveness standards.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may rely on unapproved diagnostic information, which could lead to inappropriate medical decisions or delays in proper care.
Practical Guidance
How to identify if yours is affected
- Check EAN 616612785923 on packaging or device label.
- Check SKU A500 on packaging.
- Note that all lots are affected.
Where to find product info
Model numbers and lot information appear on the device label and packaging.
What timeline to expect
Refunds or replacements, if offered, typically completed within 4-6 weeks after verification.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to FDA consumer complaints if the company is unresponsive.
How to prevent similar issues
- Always verify FDA clearance or premarket approval before purchasing diagnostic devices.
- Prefer FDA-cleared or FDA-approved tests from reputable brands.
- Keep receipts and packaging until issues are resolved.
Documentation advice
Save the recall notice, product packaging, and all correspondence with the manufacturer for records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model numbers: EAN 616612785923; SKU A500; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the United States. No price data available.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Nationwide US distribution
- Class II recall
- No UDI-DI listed
- All lots affected
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
