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
- Diagnostic Test Kit
- Model numbers
- EAN: 7340221709188, SKU: U240, 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 Food Sensitivity Test Large is a diagnostic device intended to assess food sensitivities. It is used in a healthcare context or consumer settings under professional guidance.
Why This Is Dangerous
The hazard is regulatory in nature. Distributing a device without required FDA premarket approval or clearance raises concerns about safety and efficacy information supporting its use.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Consumers who own the affected unit should stop use and seek guidance from a healthcare provider. The recall affects only 3 units and does not indicate injuries, but it could lead to delays in proper diagnosis if used.
Practical Guidance
How to identify if yours is affected
- Verify the product name Food Sensitivity Test Large and brand GET TESTED INTERNATIONAL AB.
- Check for EAN 7340221709188 or SKU U240.
- Confirm lot/serial number status is All Lots.
Where to find product info
Refer to the FDA recall page linked in the notice for official instructions and contact details.
What timeline to expect
No remediation timeline is provided in the summary. Follow manufacturer instructions and monitor the FDA notice for updates.
If the manufacturer is unresponsive
- Document your inquiries with GET TESTED INTERNATIONAL AB
- Escalate to consumer protection or FDA if manufacturer is unresponsive
- Keep copies of all correspondence and the recall notice.
How to prevent similar issues
- In future, verify FDA clearance or premarket approval before purchasing diagnostic devices.
- Buy from reputable retailers and verify product recalls via the FDA database.
- Ask for documentation of regulatory approval when acquiring medical devices.
Documentation advice
Keep recall notices, product packaging, purchase receipts, and all correspondence with the manufacturer for records.
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Product Details
Model numbers: EAN 7340221709188, SKU U240, UDI-DI: None, Lot/Serial Number: All Lots Sold in the United States nationwide (distribution only). Other details such as price and specific sold-from dates are not provided.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- USA nationwide distribution
- Hazard: distribution without premarket approval/clearance
- Model numbers include EAN 7340221709188 and SKU U240
- All Lots are affected
- No injuries reported to date
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Safety Guide
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