GET TESTED INTERNATIONAL recalled 3 Gut Microbiome Test Large kits sold nationwide in the United States after regulators flagged distribution without premarket approval. The recall centers on a lack of FDA clearance for the device. Consumers and healthcare providers should stop using the device immediately and follow 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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This is a gut microbiome test kit intended to analyze stool samples to profile gut bacteria and inform health-related decisions.
The recall concerns distribution without FDA premarket approval or clearance, a regulatory deficiency affecting oversight and reliability of the product.
This recall is not part of a broader industry pattern.
Limited to 3 units in the U.S. The lack of clearance could cast doubt on test results and patient guidance.
FDA enforcement report Z-0778-2026 on FDA.gov and the manufacturer recall notice.
Recall remedies and refunds are not specified in the notice.
Keep the recall letter, all communications with the company, and photos of the product and identifiers.
Model numbers and identifiers: EAN 616612785893; SKU A130; UDI-DI: None; Lot/Serial Number: All Lots. Distribution: US nationwide. Quantity: 3 units. Sold by: GET TESTED INTERNATIONAL (brand standardized). Recall date: 2025-11-03. Report date: 2025-12-10. Status: ACTIVE. Category: Health & Personal Care, Medical Devices.
No injuries or incidents have been reported.
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