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 Intolerance Test
- Model numbers
- EAN: 616612785626, SKU: 1G1, 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
December 17, 2025
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 Small is designed to help individuals identify food intolerances. Consumers typically purchase such tests to manage dietary sensitivities and improve their overall health.
Why This Is Dangerous
The lack of premarket approval means the device has not undergone the necessary evaluations to ensure its safety and efficacy for consumers. This could lead to inaccurate results and health risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers who possess this device are urged to stop using it immediately, which may cause inconvenience for those relying on it for dietary management.
Practical Guidance
How to identify if yours is affected
- Check for the model number EAN: 616612785626 or SKU: 1G1 on your device.
- Verify if your product's lot number matches 'All Lots' as mentioned in the recall notice.
- Consult the recall notification letter for additional details.
Where to find product info
Model numbers and lot numbers can typically be found on the product packaging or the device itself.
What timeline to expect
Expect 4-6 weeks for refund or replacement processing from the manufacturer.
If the manufacturer is unresponsive
- Document your communication attempts with the manufacturer.
- Consider reaching out to the FDA for further assistance.
- Keep records of your purchase as proof for potential refunds.
How to prevent similar issues
- Always check for FDA approval when buying medical devices.
- Research product reviews and safety records before purchase.
- Consult healthcare professionals for recommendations.
Documentation advice
Keep a copy of the recall notification, any correspondence with the manufacturer, and receipts as proof of purchase.
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Product Details
The Food Intolerance Test Small is classified as a Class II medical device. It was distributed nationwide in the US. The model numbers affected include EAN: 616612785626, SKU: 1G1, and all lots.
Key Facts
- Class II medical device
- No reported injuries
- Immediate cessation of use advised
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Safety Guide
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