GET TESTED INTERNATIONAL AB recalled 16 Food Intolerance Test Medium devices distributed nationwide in the United States. The devices were distributed without premarket approval or clearance. Consumers should stop using the device immediately and follow the manufacturer’s recall 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 Medium is presented as a diagnostic device to analyze food intolerances. It is marketed to patients and clinicians for home or clinical use.
The hazard stems from distributing a diagnostic device without required regulatory authorization. This can undermine clinical decisions and patient trust.
This recall is not described as part of a broader industry pattern.
Patients may rely on unapproved testing, potentially delaying appropriate medical care or incurring costs for tests that lack regulatory oversight.
Recall notice and FDA enforcement page linked in the source
Refund or replacement processing generally 4-6 weeks after submission
Keep recall notice, serial/model numbers, packaging photos, and all communications with the manufacturer
Brand: GET TESTED INTERNATIONAL AB Product: Food Intolerance Test Medium Model numbers: EAN 616612785633; SKU 1B3 Distribution: US Nationwide Recall date: 2025-11-03 Report date: 2025-12-10 Quantity recalled: 16 units Price: Unknown Lot/Serial Number: All Lots
No injuries or incidents have been reported.
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