GET TESTED INTERNATIONAL AB recalled 47 Blood Type Test units distributed nationwide in the United States after discovering the device was distributed without FDA premarket approval or clearance. The hazard is distribution without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and contact GET TESTED INTERNATIONAL AB for 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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Blood Type Test is used to determine ABO and Rh type from a blood sample through in vitro testing. It is marketed for clinical or consumer use where typing is required.
The recall is grounded in distribution without FDA premarket approval or clearance, reflecting regulatory noncompliance rather than a direct device failure.
This recall is not stated as part of a broader industry pattern.
Consumers may be using a device that lacks regulatory clearance, potentially affecting confidence in results and leading to replacement needs.
Label on the device, packaging, and the FDA recall page for Z-0728-2026.
Refund or replacement typically 4-8 weeks after claim submission.
Keep photos of the product and label, receipts, and all correspondence with the manufacturer.
Model numbers: EAN 7340221708136. SKU: A-BG. UDI-DI: None. Lot/Serial Number: All Lots. Distribution: US Nationwide. Sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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