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
- Pet Allergy Test
- Model numbers
- EAN: 616612785695, SKU: TI, 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 Pet Allergy Test is designed for pet owners seeking to identify allergies in their pets. Consumers purchase this device to better understand their pets' health and manage allergy symptoms.
Why This Is Dangerous
The hazard arises from the distribution of the device without proper regulatory clearance, which means it may not meet safety standards. This could lead to inaccurate testing results or potential health risks for pets and their owners.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects pet owners who may have relied on the test for allergy management. Users are urged to stop using the device, which may cause inconvenience and concern.
Practical Guidance
How to identify if yours is affected
- Check if the purchased Pet Allergy Test has model identifiers EAN: 616612785695 or SKU: TI.
- Verify if the product was purchased after the recall date of November 3, 2025.
- Contact GET TESTED INTERNATIONAL AB for clarification on affected units.
Where to find product info
Model identifiers can usually be found on the product packaging or user manual.
What timeline to expect
Expect a refund processing timeline of approximately 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Reach out to consumer protection agencies for assistance.
- Consider filing a complaint with the FDA if necessary.
How to prevent similar issues
- Look for FDA-approved medical devices in the future.
- Research device manufacturers and their compliance with regulations.
- Check for reviews and safety certifications before purchase.
Documentation advice
Keep records of purchase receipts, correspondence with the manufacturer, and any photos of the product.
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Product Details
The recalled product is the Pet Allergy Test with model identifiers EAN: 616612785695, SKU: TI. It was distributed nationwide in the U.S. and is classified as a Class II medical device.
Key Facts
- Recalled on November 3, 2025
- Class II medical device
- Stop using immediately
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Safety Guide
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