GET TESTED INTERNATIONAL AB recalled 100 Kidney Test devices sold nationwide in the United States. The recall cites distribution without premarket approval or clearance. Healthcare providers and patients should stop using the device immediately and follow manufacturer 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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The Kidney Test is a diagnostic device marketed for kidney-related assessment. It is distributed nationwide in the United States through healthcare channels.
The hazard stems from distributing a device without FDA premarket approval or clearance. This creates regulatory and safety concerns for users.
This recall is not described as part of a broader industry pattern.
Up to 100 units were distributed with no reported injuries. The immediate risk is regulatory noncompliance and potential safety concerns for patients.
Labeling on the device, packaging, and the recall notice from the manufacturer. FDA recall page Z-0800-2026.
Typical refund or replacement timelines are not specified by the recall; providers recommend contacting the manufacturer for resolution.
Keep all recall notices, packaging, model numbers, and date codes; log communications with the manufacturer and healthcare providers.
Brand: GET TESTED INTERNATIONAL AB Product: Kidney Test Model numbers: EAN 7340221701731; SKU D-KID; UDI-DI None; Lot/Serial Number: All Lots Sold at: Nationwide distribution in the United States through healthcare providers Sold since: Unknown Price: Unknown
No injuries or incidents have been reported.
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