GET TESTED INTERNATIONAL AB recalled 47 blood type tests on November 3, 2025. The recall results from distribution without premarket approval. Patients and healthcare providers must 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 recalled blood type test is classified as a Class II medical device. It is identified by EAN: 7340221708136 and SKU: A-BG. Distribution occurred nationwide across the United States.
This blood type test was distributed without the necessary premarket approval or clearance. The lack of approval means the test has not undergone the required safety and effectiveness evaluations.
No specific incidents or injuries have been reported in connection with this recall. The risk level is deemed high due to the lack of regulatory approval.
Patients and healthcare providers should stop using the blood type test immediately. Contact GET TESTED INTERNATIONAL AB or a healthcare provider for further instructions. Follow any recall instructions provided via letter.
For more information, contact GET TESTED INTERNATIONAL AB. Visit their website or reach out through provided healthcare channels.
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