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 is designed to analyze gut health by assessing the microbiome composition. Consumers purchase this test to gain insights into their digestive health and dietary needs.
Distribution without premarket approval means the device has not undergone sufficient regulatory review for safety and efficacy. This raises concerns about the reliability of the results it provides.
This recall is not part of a broader industry pattern.
Consumers must stop using the product immediately. There may be a delay in receiving alternative testing options.
The model numbers can usually be found on the packaging or the device itself.
Expect a refund or alternative instructions within 4-6 weeks after contacting the manufacturer.
Keep all correspondence regarding the recall and any receipts or records of purchase.
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.
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