Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GET TESTED INTERNATIONAL AB
- Product type
- Gut Microbiome Test
- Model numbers
- EAN: 616612785909, SKU: A020, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
December 17, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Distribution without premarket approval/clearance.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
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.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers must stop using the product immediately. There may be a delay in receiving alternative testing options.
Practical Guidance
How to identify if yours is affected
- Check the model number: EAN: 616612785909 or SKU: A020.
- If the product was purchased, verify the recall notice you received.
- Determine if you have received any notification from GET TESTED INTERNATIONAL AB.
Where to find product info
The model numbers can usually be found on the packaging or the device itself.
What timeline to expect
Expect a refund or alternative instructions within 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Document all communication with the manufacturer.
- Consider reaching out to the FDA for assistance.
How to prevent similar issues
- Always check for FDA approval before purchasing medical devices.
- Look for third-party testing or certifications when considering health-related products.
- Research the company behind health products to ensure credibility.
Documentation advice
Keep all correspondence regarding the recall and any receipts or records of purchase.
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Product Details
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.
Key Facts
- Recall date: November 3, 2025
- Four units recalled
- High hazard level
- Contact GET TESTED INTERNATIONAL AB for instructions
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Safety Guide
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