GET TESTED INTERNATIONAL AB recalled eight units of the Fructose Intolerance Test on November 3, 2025. The recall occurs due to distribution without premarket approval. Patients and healthcare providers should 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 recalled product is the Fructose Intolerance Test, identified by EAN: 616612787323 and SKU: 2B120. The recall involves all lots of the product. It was distributed nationwide in the United States.
The Fructose Intolerance Test was distributed without the necessary premarket approval or clearance. This classification as a Class II device indicates a moderate to high risk to patients.
There have been no reported incidents or injuries associated with this recall. However, the lack of premarket approval raises concerns about safety and efficacy.
Stop using the Fructose Intolerance Test immediately. Follow the recall instructions provided by GET TESTED INTERNATIONAL AB. Contact your healthcare provider for further guidance.
For more information, contact GET TESTED INTERNATIONAL AB. Visit the FDA website for details on the recall.
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