GET TESTED INTERNATIONAL AB recalled 36 NAD Profile Tests distributed nationwide in the United States after regulators found distribution without premarket approval. The devices were distributed without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow recall instructions; contact GET TESTED INTERNATIONAL AB or your health‑ca
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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NAD Profile Test appears to be a diagnostic device used in health and personal care. It is distributed nationwide in the United States and has a model listing including an EAN and SKU. The recall concerns regulatory compliance rather than an explicit product defect.
The device was distributed without premarket approval or clearance. This regulatory issue could impact patient safety if the device were used in a clinical setting.
This recall is not described as part of a broader industry pattern in the notice.
Consumers and healthcare providers must stop using the device and follow recall instructions. The impact is primarily regulatory risk and potential disruption to testing workflows.
FDA enforcement recall page linked in the notice: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0766-2026
Remedies such as refunds or replacements may take weeks to months depending on manufacturer processes and regulatory approvals
Keep copies of recall notices, communications with manufacturer, purchase records, and any packaging labels.
Model numbers: EAN 7340221709270; SKU UNAD; UDI-DI: None; Lot/Serial Number: All Lots. Quantity recalled: 36 units. Distribution: US nationwide. Recall date: 2025-11-03. Report date: 2025-12-10. Status: ACTIVE.
No injuries or incidents have been reported.
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