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
- Allergy Test
- Model numbers
- EAN: 616612785602, SKU: 1CO, 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 13, 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 Allergy Test Small by GET TESTED INTERNATIONAL AB is designed for allergy testing. Consumers typically purchase it to identify potential allergens that may cause reactions.
Why This Is Dangerous
The device's distribution without premarket approval means it has not undergone necessary safety and efficacy evaluations. This raises concerns about its reliability and potential health risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers must stop using the product to avoid potential health risks. The recall does not appear to have caused any reported injuries, but it is crucial to act quickly.
Practical Guidance
How to identify if yours is affected
- Check if you have the Allergy Test Small by GET TESTED INTERNATIONAL AB.
- Verify the model number: EAN: 616612785602 or SKU: 1CO.
- Stop using the product immediately.
Where to find product info
The model number can typically be found on the product packaging or the device itself.
What timeline to expect
Expect a response regarding refunds or replacements within 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Contact your healthcare provider for assistance.
- File a complaint with the FDA if no response is received.
How to prevent similar issues
- Always check for FDA approval when purchasing medical devices.
- Look for certifications or safety markings on testing products.
- Research the manufacturer's reputation before buying health-related products.
Documentation advice
Keep records of your purchase, including receipts and any correspondence with the manufacturer.
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Product Details
The recalled product is the Allergy Test Small by GET TESTED INTERNATIONAL AB. It includes models EAN: 616612785602 and SKU: 1CO. The product was distributed nationwide in the U.S.
Key Facts
- Distributed nationwide in the U.S.
- Class II recall due to lack of approval
- Immediate stop-use instructions issued
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Safety Guide
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