GET TESTED INTERNATIONAL AB recalled 1,557 Vitamin D-Tests on November 3, 2025, due to distribution without premarket approval. The recall affects devices distributed nationwide in the United States. Consumers should stop using the test 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 recall involves the Vitamin D-Test, identified by EAN: 7340221700802 and SKU: A-VID. It was distributed nationwide throughout the U.S. since its release. The quantity recalled is 1,557 units.
The Vitamin D-Test was distributed without the necessary premarket approval from the FDA. This poses potential risks as the device may not meet safety and effectiveness standards.
No specific incidents or injuries have been reported related to the use of this device. However, the lack of premarket approval raises serious safety concerns.
Stop using the Vitamin D-Test immediately. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for further instructions. Follow the recall instructions provided in the notification letter.
For more information, contact GET TESTED INTERNATIONAL AB through their official communication channels. Additional details are available at the FDA recall website.
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