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 designed to help individuals identify food intolerances. Consumers typically purchase such tests to manage dietary sensitivities and improve their overall health.
The lack of premarket approval means the device has not undergone the necessary evaluations to ensure its safety and efficacy for consumers. This could lead to inaccurate results and health risks.
This recall is not part of a broader industry pattern.
Consumers who possess this device are urged to stop using it immediately, which may cause inconvenience for those relying on it for dietary management.
Model numbers and lot numbers can typically be found on the product packaging or the device itself.
Expect 4-6 weeks for refund or replacement processing from the manufacturer.
Keep a copy of the recall notification, any correspondence with the manufacturer, and receipts as proof of purchase.
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.
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