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, PREGNANT, 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 Kit
- Model numbers
- EAN: 616612785879, SKU: 2A110, 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 analyze stool samples to profile gut bacteria and are used to guide health discussions with providers.
Why This Is Dangerous
The recall concerns distribution without FDA premarket approval or clearance, raising regulatory and safety questions about the device.
Industry Context
This recall is not shown to be part of a broader industry pattern in the provided data.
Real-World Impact
A total of 6 units across the US are affected. The issue is regulatory rather than an immediate clinical injury, but users should not rely on this device until cleared.
Practical Guidance
How to identify if yours is affected
- Check for model EAN 616612785879 on the product label.
- Check SKU 2A110 on packaging or documentation.
- Note that Lot/Serial Number: All Lots means any batch is affected.
Where to find product info
FDA recall page and the manufacturer for instructions. FDA enforcement report Z-0781-2026 provides official notice.
What timeline to expect
No specific refund/replacement timeline provided in the recall notice.
If the manufacturer is unresponsive
- Escalate to consumer protection or contact FDA for guidance.
- File a complaint if the company delays or refuses refunds.
How to prevent similar issues
- In the future verify FDA premarket clearance or FDA approval status before distributing medical tests.
- Confirm device clearance status with the manufacturer prior to purchase.
- Keep all recall notices and documentation for records.
Documentation advice
Retain the recall notice, purchase receipts, and correspondence with the manufacturer. Photograph labeling and lot numbers.
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Product Details
Model numbers: EAN 616612785879; SKU 2A110; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the United States. Sold date: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product: Gut Microbiome Test Small
- Lot/Serial: All Lots
- Nationwide US distribution
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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