Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL
- 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
- Product type
- Diagnostic Test Kit (H. pylori)
- Model numbers
- EAN: 616612787309, SKU: 2-B220, 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 product is a diagnostic test kit designed to detect Helicobacter pylori infection associated with peptic ulcers. It was distributed nationwide in the United States.
Why This Is Dangerous
The primary hazard is distribution without FDA premarket approval or clearance, which may cast doubt on safety and effectiveness of the diagnostic results.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers and healthcare providers may rely on unvetted test results. The recall affects 12 units and requires immediate discontinuation of use.
Practical Guidance
How to identify if yours is affected
- Check the product against the recall identifiers: EAN 616612787309 and SKU 2-B220.
- Review Lot/Serial Number: All Lots.
- Confirm the quantity you own is 12 units.
Where to find product info
Recall letter from the manufacturer and FDA enforcement page linked in the recall notice.
What timeline to expect
Refunds or replacements, if offered, typically take several weeks to process.
If the manufacturer is unresponsive
- Document all communication attempts with the manufacturer.
- Consider filing a complaint with the FDA if the manufacturer is non-responsive.
How to prevent similar issues
- Verify regulatory approvals before acquiring diagnostic tests.
- Avoid purchasing medical devices from unverified sources.
- When in doubt, seek tests with clear FDA clearance/approval.
Documentation advice
Keep the recall letter, purchase records, and correspondence with the manufacturer as part of your records.
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Product Details
Model numbers: EAN 616612787309; SKU 2-B220; UDI-DI: None; Lot/Serial Number: All Lots; Quantity: 12 units; Distribution: US nationwide; Sold since: Recall date 2025-11-03; Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Brand: GET TESTED INTERNATIONAL AB
- Model numbers: EAN 616612787309; SKU: 2-B220
- UDI-DI: None; Lot/Serial Number: All Lots
- Recall number: Z-0794-2026
- Recall date: 2025-11-03 (recall initiation) and report date 2025-12-10 (active)
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Safety Guide
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