GET TESTED INTERNATIONAL AB recalled 3 units of the Food Sensitivity Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers should stop using this 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 recall involves the Food Sensitivity Test Small, identified by EAN: 7340221709164 and SKU: U96. The device was distributed nationwide in the United States.
The Food Sensitivity Test was distributed without the necessary premarket approval or clearance from regulatory authorities. This poses significant risks as the safety and efficacy of the product have not been verified.
No specific incidents or injuries have been reported related to this recall. The potential for harm exists due to the lack of regulatory approval.
Stop using the Food Sensitivity Test immediately. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for further instructions and to follow the recall process.
Reach GET TESTED INTERNATIONAL AB at their customer service line or through their official website for assistance.
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