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
- Pollen Allergy Test
- Model numbers
- EAN: 616612785688, SKU: 1EP, 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
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 Pollen Allergy Test is designed for individuals to test for pollen allergies. Consumers typically purchase such tests to identify specific allergens and manage their symptoms effectively.
Why This Is Dangerous
The hazard stems from the lack of premarket approval, which means the product has not undergone necessary safety and efficacy evaluations. This raises concerns about its reliability and potential health risks during use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall requires consumers to stop using the product immediately, which may cause inconvenience and necessitate seeking alternative testing methods.
Practical Guidance
How to identify if yours is affected
- Check the model number on the packaging or device.
- Verify if it matches EAN: 616612785688 or SKU: 1EP.
- Confirm if the product was purchased recently from a retailer.
Where to find product info
Model numbers can typically be found on the product packaging or instruction manual.
What timeline to expect
Expect a response regarding refunds or replacements within 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Follow up with GET TESTED INTERNATIONAL AB via phone or email.
- Document your attempts to contact the company for records.
How to prevent similar issues
- Always check for FDA approval before purchasing medical devices.
- Look for established brands with a track record of safety compliance.
- Read reviews and reports on medical devices before use.
Documentation advice
Keep records of your purchase, including receipts and correspondence with the manufacturer.
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Product Details
The recalled Pollen Allergy Test has model numbers EAN: 616612785688 and SKU: 1EP. It was distributed nationwide in the U.S. All lots of the product are affected.
Key Facts
- Distribution without premarket approval
- Affected model: EAN: 616612785688
- Affected model: SKU: 1EP
- Stop using immediately
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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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