Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- 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 AB
- Product type
- Food Intolerance Test Medium
- Model numbers
- EAN: 616612785633, SKU: 1B3
- 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
The Food Intolerance Test Medium is presented as a diagnostic device to analyze food intolerances. It is marketed to patients and clinicians for home or clinical use.
Why This Is Dangerous
The hazard stems from distributing a diagnostic device without required regulatory authorization. This can undermine clinical decisions and patient trust.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Patients may rely on unapproved testing, potentially delaying appropriate medical care or incurring costs for tests that lack regulatory oversight.
Practical Guidance
How to identify if yours is affected
- Check product label for 'Food Intolerance Test Medium'
- Verify model numbers: EAN 616612785633 and SKU 1B3
- Confirm that Lot/Serial Number indicates All Lots
- Compare to recall notice reference materials
Where to find product info
Recall notice and FDA enforcement page linked in the source
What timeline to expect
Refund or replacement processing generally 4-6 weeks after submission
If the manufacturer is unresponsive
- Escalate to manufacturer via official recall channels
- File a complaint with FDA if unresponsive for medical-device concerns
- Consider contacting consumer protection agencies for assistance
How to prevent similar issues
- Verify regulatory clearance before purchasing diagnostic tests
- Seek FDA-cleared or clinically validated tests
- Consult a healthcare professional before acting on test results
Documentation advice
Keep recall notice, serial/model numbers, packaging photos, and all communications with the manufacturer
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Product Details
Brand: GET TESTED INTERNATIONAL AB Product: Food Intolerance Test Medium Model numbers: EAN 616612785633; SKU 1B3 Distribution: US Nationwide Recall date: 2025-11-03 Report date: 2025-12-10 Quantity recalled: 16 units Price: Unknown Lot/Serial Number: All Lots
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution
- Model numbers: EAN 616612785633; SKU 1B3
- All lots affected
- No injuries reported
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Safety Guide
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