GET TESTED INTERNATIONAL AB recalled 3 units of its Food Sensitivity Test Large sold nationwide in the United States. The device was distributed without FDA premarket approval or clearance. Consumers should stop using it and contact GET TESTED INTERNATIONAL AB or their healthcare provider for 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 Sensitivity Test Large is a diagnostic device intended to assess food sensitivities. It is used in a healthcare context or consumer settings under professional guidance.
The hazard is regulatory in nature. Distributing a device without required FDA premarket approval or clearance raises concerns about safety and efficacy information supporting its use.
This recall is not described as part of a broader industry pattern in the provided information.
Consumers who own the affected unit should stop use and seek guidance from a healthcare provider. The recall affects only 3 units and does not indicate injuries, but it could lead to delays in proper diagnosis if used.
Refer to the FDA recall page linked in the notice for official instructions and contact details.
No remediation timeline is provided in the summary. Follow manufacturer instructions and monitor the FDA notice for updates.
Keep recall notices, product packaging, purchase receipts, and all correspondence with the manufacturer for records.
Model numbers: EAN 7340221709188, SKU U240, UDI-DI: None, Lot/Serial Number: All Lots Sold in the United States nationwide (distribution only). Other details such as price and specific sold-from dates are not provided.
No injuries or incidents have been reported.
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