GET TESTED INTERNATIONAL AB recalled 15 units of its Lactose Intolerance Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers must stop using the device immediately.
Distribution without premarket approval/clearance.
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
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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.
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.
This recall is not part of a broader industry pattern.
Consumers may face health risks from using this unapproved test. Stopping its use is critical to ensure safety.
You can find the model identifiers on the product packaging or accompanying documentation.
Expect 4-6 weeks for refund processing after returning the product.
Keep records of all communications with the manufacturer, as well as any medical advice received regarding the device.
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.
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