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
- Urinary Tract Infection Test
- Model numbers
- EAN: 7340221700529, SKU: A-URI, 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
December 17, 2025
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 Urinary Tract Infection Test is designed for at-home use to detect urinary tract infections. Consumers buy this product for convenience and quick results.
Why This Is Dangerous
The lack of premarket approval/clearance means the product has not been evaluated for safety and effectiveness, posing potential health risks to users.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face inconvenience due to the recall and should seek alternative testing methods to ensure accurate diagnosis.
Practical Guidance
How to identify if yours is affected
- Check for the model number EAN: 7340221700529 or SKU: A-URI on the packaging.
- Verify if your product is among the recalled 40 units by contacting the manufacturer.
- Look for a notification letter from GET TESTED INTERNATIONAL AB regarding the recall.
Where to find product info
Check the product packaging for model numbers and any identifying information, including lot numbers.
What timeline to expect
Expect a response regarding refunds or replacements within 4-6 weeks.
If the manufacturer is unresponsive
- Keep records of all correspondence with the manufacturer.
- Contact the FDA if the manufacturer does not respond promptly.
How to prevent similar issues
- Look for FDA-approved medical devices in the future.
- Check for clear labeling on medical devices regarding approval status.
- Consult healthcare professionals before using new medical devices.
Documentation advice
Keep a record of your purchase, including receipts, and any correspondence related to the recall.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled product is the Urinary Tract Infection Test, with model numbers EAN: 7340221700529 and SKU: A-URI. The product was distributed nationwide in the United States. No specific price was mentioned.
Key Facts
- Recall date: November 3, 2025
- Quantity recalled: 40 units
- Classification: Class II
- Distribution: Nationwide in the US
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.