GET TESTED INTERNATIONAL AB's SIBO Test was distributed nationwide in the United States. The device was distributed without FDA premarket approval or clearance. Stop using the device immediately and follow the recall instructions from the manufacturer.
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 SIBO Test is a diagnostic device marketed for testing small intestinal bacterial overgrowth. It is intended for use by patients and healthcare providers in GI evaluations.
The device was distributed without FDA premarket approval or clearance, which is a regulatory defect that may affect patient safety and treatment decisions.
This recall is not described as part of a broader industry pattern in the notice.
If used, patients could receive tests that lack approved regulatory oversight. No injuries are reported in the notice, but the regulatory issue could affect clinical decision-making.
Labeling on the device and accompanying packaging; recall notice from manufacturer and FDA enforcement page
Recall processing details not provided; typically 4-8 weeks for guidance and action steps
Keep the recall notification, sales records, labeling, and all correspondence with the manufacturer
Model numbers: EAN 616612785947; SKU B105; UDI-DI: None; Lot/Serial Number: All Lots. Quantity: 55 units. Sold nationwide in the United States. Recall date: 2025-11-03. Report date: 2025-12-10. Status: ACTIVE. Brand: GET TESTED INTERNATIONAL AB.
No injuries or incidents have been reported.
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