GET TESTED INTERNATIONAL AB recalled 2 Gut Microbiome Test Mega units distributed nationwide in the United States. The recall centers on distribution without premarket approval or clearance. Consumers should stop using the device and contact the manufacturer for instructions. The notice was issued in 2025 and is currently active.
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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Gut microbiome tests are diagnostic tools used to analyze gut bacteria composition. They are bought by consumers seeking insights into gut health and diet planning.
The root hazard is distribution without FDA premarket approval or clearance, which can undermine test validity and patient safety.
This recall is not part of a broader industry pattern.
Minimal direct risk due to only two units, but it raises concerns about regulatory compliance and test result reliability for patients.
Model numbers and lot information appear on device packaging and documentation.
Not specified by the recall notice.
Preserve the recall letter, packaging, model numbers, and any correspondence with the manufacturer for refunds or replacement requests.
Model numbers: EAN 616612786944; SKU 2A713BWG-A500; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the United States. Price not disclosed. Sold date not specified.
No injuries or incidents have been reported.
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