GET TESTED INTERNATIONAL AB recalled 50 units of its Heavy Metals Test on November 3, 2025. The recall follows distribution without premarket approval or clearance, posing potential health risks. Healthcare providers and patients must stop using the device immediately.
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 Heavy Metals Test by GET TESTED INTERNATIONAL AB is classified as a Class II medical device. It was distributed nationwide in the US. The recalled products include all lots with the following identifiers: EAN: 616612785749, SKU: 1SM.
The device was distributed without the required premarket approval, raising concerns about its safety and efficacy. The FDA has classified this issue as a Class II recall, indicating a high risk of illness or injury.
There are no reported incidents of injury or illness associated with this recall. The potential for harm exists due to the lack of regulatory clearance.
Patients and healthcare providers should immediately stop using the Heavy Metals Test. Follow the recall instructions provided by GET TESTED INTERNATIONAL AB. Contact the manufacturer or your healthcare provider for further guidance.
For further assistance, contact GET TESTED INTERNATIONAL AB or your healthcare provider. More details are available at the FDA's recall page.
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