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
- Model numbers
- EAN: 7340221709263, SKU: UOAL, 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 Organic Acids Profile Test Large is a diagnostic tool used to analyze organic acids in biological samples. Consumers typically purchase this test for health assessments and metabolic evaluations.
Why This Is Dangerous
The hazard arises from the lack of FDA premarket approval, which means the product has not been reviewed for safety and effectiveness. This can lead to inaccurate results and potential health risks for users.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall requires immediate action from consumers and healthcare providers to prevent potential misuse. The lack of approval could lead to unsafe health decisions based on unverified results.
Practical Guidance
How to identify if yours is affected
- Check if you have the Organic Acids Profile Test Large from GET TESTED INTERNATIONAL AB.
- Verify the model number: EAN: 7340221709263 or SKU: UOAL.
- If you have the product, it is subject to recall.
Where to find product info
Look for the EAN or SKU on the product packaging or documentation.
What timeline to expect
Expect a response regarding refunds or replacements within 4-6 weeks.
If the manufacturer is unresponsive
- Contact GET TESTED INTERNATIONAL AB again.
- Report to the FDA if there is no response.
How to prevent similar issues
- Only purchase FDA-approved medical devices.
- Research products before use to ensure they have necessary approvals.
- Stay informed about recalls in the medical device industry.
Documentation advice
Keep records of your purchase, any correspondence with the manufacturer, and document any health issues encountered.
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Product Details
The recalled product is the Organic Acids Profile Test Large by GET TESTED INTERNATIONAL AB. It has a model number EAN: 7340221709263, SKU: UOAL, and includes all lots. The product distributed nationwide in the U.S.
Key Facts
- Recall date: November 3, 2025
- High hazard level
- Distribution without premarket approval
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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