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 Mega
- Model numbers
- EAN 616612786944, SKU 2A713BWG-A500, 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
April 18, 2026
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
Gut microbiome tests are diagnostic tools used to analyze gut bacteria composition. They are bought by consumers seeking insights into gut health and diet planning.
Why This Is Dangerous
The root hazard is distribution without FDA premarket approval or clearance, which can undermine test validity and patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Minimal direct risk due to only two units, but it raises concerns about regulatory compliance and test result reliability for patients.
Practical Guidance
How to identify if yours is affected
- Verify model numbers via packaging or documentation.
- Check for EAN 616612786944 and SKU 2A713BWG-A500.
- Confirm lot/serial number status: All Lots affected.
Where to find product info
Model numbers and lot information appear on device packaging and documentation.
What timeline to expect
Not specified by the recall notice.
If the manufacturer is unresponsive
- File a complaint with the FDA if the manufacturer is unresponsive.
- Keep records of all communications and the recall notice.
How to prevent similar issues
- Only purchase from verified distributors.
- Verify regulatory clearance status before use.
- Keep a copy of the recall notice and monitor updates.
Documentation advice
Preserve the recall letter, packaging, model numbers, and any correspondence with the manufacturer for refunds or replacement requests.
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Product Details
Model numbers: EAN 616612786944; SKU 2A713BWG-A500; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the United States. Price not disclosed. Sold date not specified.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Nationwide US distribution
- Model numbers: EAN 616612786944; SKU 2A713BWG-A500
- No injuries reported
- Manufacturer contact required for remedy
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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