GET TESTED INTERNATIONAL AB recalled 19 units of its Hair Mineral Analysis device on November 3, 2025. The recall follows distribution without premarket approval or clearance. This action affects devices 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 recalled Hair Mineral Analysis device includes model numbers EAN: 616612786074 and SKU: E190. All lots of the device are included in this recall. The product was distributed nationwide.
The Hair Mineral Analysis device was distributed without the necessary premarket approval or clearance from the FDA. This lack of approval raises concerns about its safety and effectiveness.
There are no reported incidents or injuries associated with the recalled devices. However, the lack of regulatory approval constitutes a significant risk.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer and contact GET TESTED INTERNATIONAL AB or your healthcare provider for further instructions.
For more information, visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0783-2026.
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