GET TESTED INTERNATIONAL AB recalled one unit of its Organic Acids Profile Test Large on November 3, 2025. The recall occurred due to distribution without necessary premarket approval. Patients and healthcare providers should stop using the device immediately.
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 Organic Acids Profile Test Large is a diagnostic tool used to analyze organic acids in biological samples. Consumers typically purchase this test for health assessments and metabolic evaluations.
The hazard arises from the lack of FDA premarket approval, which means the product has not been reviewed for safety and effectiveness. This can lead to inaccurate results and potential health risks for users.
This recall is not part of a broader industry pattern.
The recall requires immediate action from consumers and healthcare providers to prevent potential misuse. The lack of approval could lead to unsafe health decisions based on unverified results.
Look for the EAN or SKU on the product packaging or documentation.
Expect a response regarding refunds or replacements within 4-6 weeks.
Keep records of your purchase, any correspondence with the manufacturer, and document any health issues encountered.
The recalled product is the Organic Acids Profile Test Large by GET TESTED INTERNATIONAL AB. It has a model number EAN: 7340221709263, SKU: UOAL, and includes all lots. The product distributed nationwide in the U.S.
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