GET TESTED INTERNATIONAL AB recalled 5 units of its Food Intolerance Test Small on November 3, 2025. The recall follows the distribution of the device without necessary premarket approval. Healthcare providers and patients must cease use immediately and follow the manufacturer's 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 Food Intolerance Test Small is classified as a Class II medical device. It was distributed nationwide in the US. The model numbers affected include EAN: 616612785626, SKU: 1G1, and all lots.
The product was distributed without premarket approval or clearance from the FDA. This raises concerns about the safety and effectiveness of the device for intended use.
No injuries or adverse incidents have been reported related to this recall. The manufacturer has taken action proactively.
Stop using the Food Intolerance Test immediately. Follow the instructions provided by GET TESTED INTERNATIONAL AB or contact your healthcare provider for further guidance.
For more information, reach out to GET TESTED INTERNATIONAL AB at the contact details provided in the recall notification letter.
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