GET TESTED INTERNATIONAL AB recalled 80 Cholesterol Test devices distributed nationwide in the United States. The recall cites distribution without premarket approval or clearance. Consumers should stop using the device and follow the manufacturer’s recall 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 cholesterol test device is marketed to measure cholesterol levels. It is distributed nationwide in the United States. Consumers may use it at home or with clinician guidance. The recall concerns regulatory clearance rather than device performance details.
The hazard stems from distributing a medical device without required premarket approval or clearance. This creates a regulatory violation risk and potential questions about safety and effectiveness.
This recall is not described as part of a broader industry pattern in the notice.
Consumers should stop using the device to avoid regulatory issues and ensure they follow manufacturer guidance for safe handling and disposal.
Look on the device label and packaging for model and SKU. The FDA enforcement report Z-0771-2026 contains recall details.
Refund or replacement timelines are not specified in the recall. Follow manufacturer instructions; processing timelines may vary.
Keep the recall letter, product packaging, model/SKU numbers, and any correspondence with the manufacturer for records.
Model numbers: EAN 7340221704459; SKU: DFI-CHT01. UDI-DI: None. Lot/Serial Number: All Lots. Sold nationwide in the United States. Quantity: 80 units. Recall date: 2025-11-03. Status: Active. Manufacturer: GET TESTED INTERNATIONAL AB.
No injuries or incidents have been reported.
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