GET TESTED INTERNATIONAL AB recalled 16 units of Food Intolerance Test Medium on November 3, 2025. The recall stems from distribution without premarket approval. Consumers should stop use immediately and follow provided instructions.
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 Food Intolerance Test Medium, with model numbers EAN: 616612785633 and SKU: 1B3. It was distributed nationwide in the United States.
The device was distributed without obtaining necessary premarket approval or clearance. This poses potential risks to patients and healthcare providers.
No specific incidents or injuries have been reported related to this recall. The product's classification as a Class II device indicates a moderate risk.
Stop using the Food Intolerance Test Medium immediately. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for further instructions.
For assistance, contact GET TESTED INTERNATIONAL AB. Additional information is available at the FDA website.
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