GET TESTED INTERNATIONAL AB recalled six units of its Food Intolerance Test on November 3, 2025. The recall stems from the distribution of the product without premarket approval or clearance. Healthcare providers and patients 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 recalled product is the Food Intolerance Test Large, with model numbers EAN: 616612785640 and SKU: 1G2. It was distributed nationwide in the U.S. The recall affects six units.
The product was distributed without the necessary premarket approval or clearance, which raises concerns about its safety and efficacy. The FDA classified this recall as Class II, indicating a moderate risk to health.
There have been no reported injuries or adverse incidents associated with the use of this product. However, the lack of approval raises potential health risks.
Patients and healthcare providers should stop using the Food Intolerance Test immediately. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for further instructions and follow the recall notification provided by the company.
For questions, contact GET TESTED INTERNATIONAL AB. Visit their website for more information or call the company directly.
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