GET TESTED INTERNATIONAL AB recalled three Food Sensitivity Test devices on November 3, 2025. The recall follows the distribution of the devices without necessary premarket approval or clearance. Healthcare providers and patients must stop using the 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 Food Sensitivity Test is identified by EAN: 7340221709188 and SKU: U240. It was distributed nationwide in the United States. The product was sold in an unknown price range.
The recall stems from the distribution of the Food Sensitivity Test without premarket approval or clearance from the FDA. This classification as a Class II device raises concerns about its safety and efficacy.
No injuries or incidents have been reported related to this recall. The FDA has classified the hazard level as high due to the potential risks posed by unapproved medical devices.
Patients and healthcare providers should immediately stop using the Food Sensitivity Test. For further instructions, contact GET TESTED INTERNATIONAL AB or consult your healthcare provider.
For more details, visit the FDA website or contact GET TESTED INTERNATIONAL AB directly. Follow the instructions provided in the notification letter.
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