GET TESTED INTERNATIONAL AB recalled 1 unit of GI Microbiome Profile Small sold nationwide in the United States. The device was distributed without premarket approval or clearance. Consumers should stop using the device immediately and follow the manufacturer’s recall instructions. Contact GET TESTED INTERNATIONAL AB or a healthcare provider for guidance.
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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GI Microbiome Profile Small is described as a diagnostic device intended to analyze gut microbiome composition. Consumers could use it to gain insights into intestinal health.
The recall centers on distribution without premarket approval or clearance. This regulatory oversight issue could affect safety and efficacy disclosures for patients and clinicians.
This recall is not presented as part of a broader industry pattern in the provided data.
The immediate practical impact is regulatory risk for patients and clinicians and potential loss of confidence in a diagnostic product. There is no reported injuries yet.
FDA enforcement page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0763-2026
Refunds or replacements, if offered, typically take 4-6 weeks after recall initiation
Keep the recall notice, packaging, model numbers, serial numbers, and all correspondence with the manufacturer for records
Model numbers: EAN 7340221709195; SKU UGS; 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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