GET TESTED INTERNATIONAL AB recalled six units of its Gut Microbiome Test on November 3, 2025. The recall occurred due to distribution without premarket approval. Patients and healthcare providers 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 recalled product is the Gut Microbiome Test Small, with model numbers EAN: 616612785879 and SKU: 2A110. It was distributed across the United States. The quantity recalled is six units.
The product was distributed without the necessary premarket approval or clearance. This lack of regulatory compliance poses potential safety risks to users.
No specific incidents or injuries associated with this recall have been reported. The recall is classified as Class II, indicating a moderate risk.
Stop using the Gut Microbiome Test immediately. Follow the recall instructions provided by the manufacturer and contact GET TESTED INTERNATIONAL AB or your healthcare provider for further instructions.
For more information, reach GET TESTED INTERNATIONAL AB via their website or contact your healthcare provider.
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