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
- Food Sensitivity Test Kit
- Model numbers
- EAN: 7340221709164, SKU: U96, 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
Food Sensitivity Test Small appears to be a diagnostic device intended for testing dietary sensitivities. It was distributed nationwide in the United States by GET TESTED INTERNATIONAL AB.
Why This Is Dangerous
The recall arises from distribution without premarket approval or clearance, a regulatory deficiency rather than an described physical hazard.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall affects a small number of units and requires immediate cessation of use. The regulatory issue may affect consumer confidence and prompt refunds or replacements.
Practical Guidance
How to identify if yours is affected
- Identify if you own GET TESTED INTERNATIONAL AB Food Sensitivity Test Small
- Verify model numbers: EAN 7340221709164 and SKU U96
- Confirm lot numbers: All Lots
Where to find product info
Recall letter from GET TESTED INTERNATIONAL AB; product packaging and labeling may include EAN and SKU
What timeline to expect
Refund or replacement timing will be provided by the manufacturer in their recall instructions
If the manufacturer is unresponsive
- Consult the FDA recall page for guidance
- Consider filing a complaint with the agency if you do not receive a timely response
- Consult a legal professional if needed
How to prevent similar issues
- Check for premarket approval or clearance indicators before purchasing diagnostic tests
- Purchase from reputable manufacturers and verify recalls through official channels
- Keep copies of recall notices and packaging for reference
Documentation advice
Retain the recall letter, packaging, receipts, and all correspondence with the manufacturer
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Product Details
Model numbers: EAN 7340221709164, SKU U96, UDI-DI None, Lot/Serial Number All Lots. Distribution: US Nationwide. Recall date: 2025-11-03. Status: Active. Brand: GET TESTED INTERNATIONAL AB.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model numbers: EAN 7340221709164; SKU U96
- All lots affected
- Distribution: US nationwide
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Safety Guide
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