GET TESTED INTERNATIONAL AB recalled 3 units of the Biological Age & Longevity Test distributed nationwide in the United States. The recall concerns distribution without premarket approval or clearance. Consumers should stop using the device and follow the manufacturer's instructions. Contact GET TESTED INTERNATIONAL AB for guidance.
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 product is a Biological Age & Longevity Test device distributed nationwide in the United States. It is marketed to assess aging-related biomarkers.
The hazard arises from distributing a medical device without the necessary premarket approval or clearance, which may affect safety and regulatory compliance.
This recall is not identified as part of a broader industry pattern.
Consumers may stop using the device and seek guidance from healthcare providers, with potential delays in obtaining validated testing results.
Check the FDA recall page Z-0774-2026 and the manufacturer communications for instructions.
Remedy processing or instructions may follow the recall notification by the manufacturer; no specific timeline is provided.
Save recall letter, product packaging, model identifiers, and correspondence with the manufacturer for future reference.
Model numbers / identifiers: EAN 616612786210; SKU H612; UDI-DI: None; Lot/Serial Number: All Lots. Quantity: 3 units. Sold nationwide in the United States. Recall date: 2025-11-03. Manufacturer: GET TESTED INTERNATIONAL AB. Price: Unknown.
No injuries or incidents have been reported.
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