GET TESTED INTERNATIONAL AB recalled 17 units of its Adrenal Test on November 3, 2025. The recall occurred due to distribution without premarket approval or clearance. Patients and healthcare providers 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 Adrenal Test is designed to assess adrenal health and hormone levels. Patients often use it for monitoring hormonal imbalances or related health conditions.
The risk arises from the lack of regulatory approval, which means the device's safety and effectiveness have not been validated. Using such a device could lead to inaccurate health assessments.
This recall is not part of a broader industry pattern.
Consumers must stop using the Adrenal Test immediately, which may cause inconvenience for those relying on it for health assessments.
Model numbers and SKU can typically be found on the packaging or device label.
Expect a refund processing timeline of 4-6 weeks after following the return instructions.
Keep all correspondence related to the recall, including letters and records of contact with the manufacturer.
The recall involves the Adrenal Test with EAN: 7340221708488 and SKU: 2O320-1CO. It was distributed nationwide in the U.S.
Not sure what to do next? Our guide walks you through the process step by step.
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