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 Vitamin D-Test is a medical device used to measure Vitamin D levels in patients. Consumers typically buy this product for health monitoring and to guide dietary or supplement decisions.
The hazard arises from the distribution of the Vitamin D-Test without the required FDA premarket approval. Devices lacking this approval may not have undergone necessary safety and efficacy evaluations, posing potential risks to patients.
This recall is not part of a broader industry pattern.
Consumers may face inconvenience as they must stop using the device and seek alternatives for monitoring Vitamin D levels. There are no immediate injuries reported, but the recall raises significant safety concerns.
You can find the EAN, SKU, and other identifiers on the product packaging or user manual.
4-6 weeks for refund processing or further instructions.
Keep records of your purchase, any correspondence with GET TESTED INTERNATIONAL AB, and photographs of the device.
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.
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