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
- Lactose Intolerance Test
- Model numbers
- EAN: 616612785978, SKU: B110, 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 Lactose Intolerance Test is used to diagnose lactose intolerance. Consumers typically purchase this test to determine their ability to digest lactose, which can help in managing dietary needs.
Why This Is Dangerous
The hazard arises from the distribution of a medical testing device without the required FDA approval, which may lead to inaccurate testing results and potential health risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face health risks from using this unapproved test. Stopping its use is critical to ensure safety.
Practical Guidance
How to identify if yours is affected
- Check for the model identifiers: EAN: 616612785978 or SKU: B110.
- Confirm if your device was purchased from an authorized retailer.
- Refer to the recall notification letter for specific instructions.
Where to find product info
You can find the model identifiers on the product packaging or accompanying documentation.
What timeline to expect
Expect 4-6 weeks for refund processing after returning the product.
If the manufacturer is unresponsive
- Contact the company again and request a confirmation of your previous communication.
- Escalate the issue to the FDA if the company remains unresponsive.
How to prevent similar issues
- Always verify FDA approval status before purchasing medical devices.
- Consult healthcare providers for recommendations on safe testing alternatives.
- Look for reliable reviews of medical devices before purchase.
Documentation advice
Keep records of all communications with the manufacturer, as well as any medical advice received regarding the device.
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Product Details
The Lactose Intolerance Test has the following identifiers: EAN: 616612785978, SKU: B110. The product was distributed nationwide in the U.S. and is classified as a Class II medical device.
Key Facts
- Class II medical device
- Hazard: Distribution without premarket approval
- Stop using the device immediately
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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