GET TESTED INTERNATIONAL AB recalled four units of the Gut Microbiome Test XL on November 3, 2025. The recall occurred due to distribution without premarket approval. Healthcare providers and patients should stop using the device immediately.
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 Gut Microbiome Test XL has model numbers EAN: 616612785909 and SKU: A020. It is classified as a Class II medical device. Four units were distributed nationwide in the United States.
The product was distributed without the necessary premarket approval or clearance. This poses a risk to patients who may rely on unverified health assessments.
There are no reported incidents of injury or adverse effects associated with the use of this device. It remains a precautionary recall.
Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by the manufacturer and contact GET TESTED INTERNATIONAL AB or your healthcare provider for further actions.
For inquiries, contact GET TESTED INTERNATIONAL AB. Visit the recall page at the FDA for more details: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0782-2026.
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