GET TESTED INTERNATIONAL AB recalled 31 Leaky Gut Test devices distributed nationwide in the United States after the product was found to be distributed without FDA premarket approval. The devices test for gut health but lack FDA clearance. Consumers should stop using the device immediately and contact the manufacturer for 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 Leaky Gut Test is marketed as a diagnostic device to assess gut permeability. It is distributed in the United States and is intended for patient use or clinician use.
The hazard arises from distribution without FDA premarket approval or clearance. Without FDA authorization, the device may not meet safety and effectiveness standards.
This recall is not part of a broader industry pattern.
Consumers may rely on unapproved diagnostic information, which could lead to inappropriate medical decisions or delays in proper care.
Model numbers and lot information appear on the device label and packaging.
Refunds or replacements, if offered, typically completed within 4-6 weeks after verification.
Save the recall notice, product packaging, and all correspondence with the manufacturer for records.
Model numbers: EAN 616612785923; SKU A500; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the United States. No price data available.
No injuries or incidents have been reported.
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