GET TESTED INTERNATIONAL AB recalled 10 Vitamin D2 and D3 Test kits distributed nationwide in the United States. The recall cites distribution without premarket approval or clearance. Patients and healthcare providers should stop using the device 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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Vitamin D2 and D3 tests are used by consumers to assess vitamin D levels. As an at-home or clinician-assisted diagnostic tool, accuracy and regulatory clearance are important for reliable results.
Distribution without premarket approval/clearance means the device may lack FDA clearance and validated safety and effectiveness data. This raises concerns about the test’s reliability and regulatory compliance.
This recall is not described as part of a broader industry pattern in the information provided.
Individuals with vitamin D testing needs may face uncertainty about test results. Affected units should be removed from use to avoid potential misdiagnosis.
Label on the packaging and any recall notifications from GET TESTED INTERNATIONAL AB or FDA recall page.
Refunds or replacements are typically processed after the company issues a remedy. Consumers should expect follow-up instructions.
Keep recall notices, photos of packaging and product, purchase records, and any correspondence with the manufacturer.
Model numbers: EAN 7340221709232 and SKU UD. UDI-DI: None. Lot/Serial Number: All Lots. Sold nationwide in the United States. Price: Unknown.
No injuries or incidents have been reported.
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