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
- Diagnostic Test Kit
- Model numbers
- EAN: 616612785947, SKU: B105, 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
The SIBO Test is a diagnostic device marketed for testing small intestinal bacterial overgrowth. It is intended for use by patients and healthcare providers in GI evaluations.
Why This Is Dangerous
The device was distributed without FDA premarket approval or clearance, which is a regulatory defect that may affect patient safety and treatment decisions.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
If used, patients could receive tests that lack approved regulatory oversight. No injuries are reported in the notice, but the regulatory issue could affect clinical decision-making.
Practical Guidance
How to identify if yours is affected
- Confirm the model using EAN 616612785947 or SKU B105
- Check batches for All Lots designation
- Review recall notice for manufacturer-specific instructions
Where to find product info
Labeling on the device and accompanying packaging; recall notice from manufacturer and FDA enforcement page
What timeline to expect
Recall processing details not provided; typically 4-8 weeks for guidance and action steps
If the manufacturer is unresponsive
- Document all communications with the manufacturer
- File a complaint with FDA if you suspect harm or noncompliance
- Consult your healthcare provider for testing alternatives
How to prevent similar issues
- Always verify FDA premarket clearance before distributing or using medical devices
- Check for FDA recall announcements before using new diagnostic devices
- Prefer products with clear, published regulatory approvals
Documentation advice
Keep the recall notification, sales records, labeling, and all correspondence with the manufacturer
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model numbers: EAN 616612785947; SKU B105; UDI-DI: None; Lot/Serial Number: All Lots. Quantity: 55 units. Sold nationwide in the United States. Recall date: 2025-11-03. Report date: 2025-12-10. Status: ACTIVE. Brand: GET TESTED INTERNATIONAL AB.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Brand GET TESTED INTERNATIONAL AB
- Model numbers EAN 616612785947, SKU B105
- Lot/Serial Number: All Lots
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.