100% of reported issues involve distribution without premarket approval. GET TESTED INTERNATIONAL AB’s HbA1c Diabetes Test was distributed nationwide in the United States without FDA clearance. Stop using the product immediately 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 HbA1c Diabetes Test is a diagnostic tool intended to measure average blood glucose levels over several weeks. It is used by patients and healthcare providers to monitor diabetes management.
Distribution without premarket approval or clearance means the device may not have demonstrated safety or effectiveness for its intended use.
This recall is not described as part of a broader industry pattern in the provided information.
Consumers may have purchased or received this device under the assumption of regulatory clearance, potentially impacting medical decision-making.
Recall URL: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0732-2026
Refunds or replacements may take 4-6 weeks after verification. Follow manufacturer instructions for processing.
Keep recall notices, order confirmations, labeling, and correspondence. Photograph all packaging and serial numbers for your records.
Model numbers: EAN 7340221707191; SKU A-HbA1c. UDI-DI: None. Lot/Serial Number: All Lots. Sold nationwide in the United States. Recall date: 2025-11-03. Report date: 2025-12-10. Price: Unknown.
No injuries or incidents have been reported.
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