GET TESTED INTERNATIONAL AB recalled three units of its Biological Age & Longevity Test on November 3, 2025, due to distribution without necessary premarket approval. The recall affects products distributed nationwide in the U.S.
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 Biological Age & Longevity Test was distributed without necessary premarket approval. It has model numbers EAN: 616612786210 and SKU: H612. The recall includes all lots.
The product was distributed without premarket approval or clearance, which poses potential risks to patients. Lack of approval means the device has not undergone necessary safety evaluations.
No incidents or injuries have been reported in association with this recall. As of now, the recall is proactive to prevent potential future risks.
Patients and healthcare providers should stop using the device immediately. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for further instructions.
For further information, call GET TESTED INTERNATIONAL AB directly or visit their website. Notification about the recall was made via letter.
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