Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Food intolerance test kit (in vitro diagnostic device)
- Model numbers
- EAN: 616612785640, SKU: 1G2, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Unknown
- 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
Food intolerance test kits are used to assess dietary intolerance. The specific device in this recall was distributed without required regulatory clearance.
Why This Is Dangerous
The device was distributed without FDA premarket approval or clearance, signaling a regulatory noncompliance rather than a consumer-use hazard described in the notice.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Impact is regulatory and access to a potentially non-cleared diagnostic device. No injuries are described in the notice. Consumers should cease use and seek guidance from the manufacturer or clinician.
Practical Guidance
How to identify if yours is affected
- Check EAN 616612785640 and SKU 1G2 on the product packaging.
- Look for Lot/Serial Number notations; All Lots are affected.
- Review the recall notice and FDA page for updates.
Where to find product info
FDA enforcement page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0806-2026
What timeline to expect
Timelines for refunds or replacements are not provided in the recall notice.
If the manufacturer is unresponsive
- Escalate by filing a complaint with the FDA recall program.
- Consider contacting a healthcare provider for guidance on alternatives.
How to prevent similar issues
- Verify regulatory clearance before purchasing diagnostic tests.
- Purchase from reputable, FDA-cleared vendors.
- Avoid unregulated diagnostic devices.
- Keep recalls and product packing information for future reference.
Documentation advice
Keep the recall notice, purchase records, and any correspondence with the manufacturer. Document dates and actions taken.
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Product Details
Brand: GET TESTED INTERNATIONAL AB Product: Food Intolerance Test Large Quantity: 6 units Sold: US nationwide distribution Recall date: 2025-11-03 Report date: 2025-12-10 Model numbers: EAN 616612785640; SKU 1G2; UDI-DI: None; Lot/Serial Number: All Lots
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution
- Model numbers: EAN 616612785640, SKU 1G2
- Lot/Serial Number: All Lots
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