GET TESTED INTERNATIONAL AB recalled 19 Hair Mineral Analysis devices distributed nationwide in the United States. The recall cites distribution without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately 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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Hair Mineral Analysis devices are used to assess mineral levels via hair samples. They are marketed to consumers or healthcare providers for diagnostic purposes.
The device was distributed without required premarket clearance, creating a regulatory and potential safety compliance risk.
This recall is not described as part of a broader industry pattern in the provided information.
No injuries reported so far. Consumers should stop use to avoid regulatory or safety uncertainties. The recall affects 19 units distributed nationwide.
Recall details available on the FDA enforcement page and the manufacturer's recall notice.
Refunds or replacements are typically processed within weeks to months depending on manufacturer and program.
Maintain the recall notice, serial numbers, model numbers, and any correspondence with the manufacturer; keep receipts if applicable.
Brand: GET TESTED INTERNATIONAL AB Product: Hair Mineral Analysis device Models: EAN 616612786074; SKU E190; UDI-DI: None; Lot/Serial Number: All Lots Sold: Nationwide in the United States Recall date: 2025-11-03 Report date: 2025-12-10 Quantity recalled: 19 units Price: Unknown Manufacturer country: Unknown Status: ACTIVE Source: FDA enforcement page linked to recall Z-0783-2026
No injuries or incidents have been reported.
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