GET TESTED INTERNATIONAL AB recalled 100 units of its Kidney Test on November 3, 2025. The recall addresses distribution without necessary premarket approval. Patients and healthcare providers should 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 recalled product is a Kidney Test manufactured by GET TESTED INTERNATIONAL AB. It was distributed nationwide in the US. The model numbers include EAN: 7340221701731 and SKU: D-KID.
The Kidney Test was distributed without premarket approval or clearance, which poses potential health risks. Products in this category require regulatory approval to ensure safety and efficacy.
No injuries or incidents have been reported associated with the use of this product. The lack of approval raises concerns about the product's reliability.
Patients and healthcare providers should stop using the Kidney Test immediately. Follow recall instructions from the manufacturer and contact GET TESTED INTERNATIONAL AB for further guidance.
For more information, contact GET TESTED INTERNATIONAL AB directly. Visit the FDA's recall page for updates on this incident.
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