GET TESTED INTERNATIONAL AB recalled 6 Gut Microbiome Test Small units distributed nationwide in the United States. The devices were distributed without FDA premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s 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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Gut microbiome tests analyze stool samples to profile gut bacteria and are used to guide health discussions with providers.
The recall concerns distribution without FDA premarket approval or clearance, raising regulatory and safety questions about the device.
This recall is not shown to be part of a broader industry pattern in the provided data.
A total of 6 units across the US are affected. The issue is regulatory rather than an immediate clinical injury, but users should not rely on this device until cleared.
FDA recall page and the manufacturer for instructions. FDA enforcement report Z-0781-2026 provides official notice.
No specific refund/replacement timeline provided in the recall notice.
Retain the recall notice, purchase receipts, and correspondence with the manufacturer. Photograph labeling and lot numbers.
Model numbers: EAN 616612785879; SKU 2A110; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the United States. Sold date: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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