GET TESTED INTERNATIONAL AB recalled 50 units of Heavy Metals Test distributed nationwide in the United States. The device was distributed without premarket FDA approval or clearance. Stop using the device immediately and contact GET TESTED INTERNATIONAL AB 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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Heavy Metals Test is a diagnostic device claimed to test for heavy metal presence. It is distributed nationwide in the US.
The device was distributed without FDA premarket approval or clearance, creating regulatory noncompliance and potential safety concerns.
This recall is not described as part of a broader industry pattern in the notice.
No injuries reported. The recall reflects regulatory risk rather than an established product hazard with reported harm.
Refer to the FDA recall page linked in the notice for official identifiers and instructions
Remedies will be provided by the manufacturer per their recall instructions. No fixed refund/replacement window is stated in the notice.
Keep the recall notice, all communications with the manufacturer, and any responses for records
Brand: GET TESTED INTERNATIONAL AB Product: Heavy Metals Test Model numbers: EAN 616612785749, SKU 1SM UDI-DI: None Lot/Serial Number: All Lots Sold: US nationwide distribution Recall date: 2025-11-03 Recall number: Z-0809-2026 Status: ACTIVE Price: Unknown
No injuries or incidents have been reported.
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