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
- Allergy test device
- Model numbers
- EAN: 616612785503, SKU: 1000, 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
April 18, 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 device is a diagnostic product intended to assess allergies. It is distributed for use in clinical or consumer settings.
Why This Is Dangerous
The hazard stems from distribution without FDA premarket approval or clearance, creating regulatory noncompliance and potential questions about device validity.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
No injuries reported. The primary impact is regulatory risk and the need for healthcare providers and patients to stop use until further instructions are issued.
Practical Guidance
How to identify if yours is affected
- Verify model information on packaging or device labeling (EAN 616612785503; SKU 1000).
- Check for Lot/Serial Number: All Lots.
- Note that UDI-DI is listed as None.
Where to find product info
Labels on the device and accompanying documentation should include the model and lot information.
What timeline to expect
4-6 weeks for refund or replacement processes if offered; exact timing not stated in recall.
If the manufacturer is unresponsive
- Document all communications with GET TESTED INTERNATIONAL AB.
- Escalate to FDA consumer complaint process if the company is unresponsive.
How to prevent similar issues
- Only purchase FDA-regulated tests from reputable sources.
- Verify the device has proper FDA clearance before use.
- Cross-check with FDA recall databases for updates.
Documentation advice
Keep the recall notice, product packaging, photos of labels, and any correspondence with the manufacturer.
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Product Details
Model numbers: EAN 616612785503; SKU 1000; UDI-DI: None; Lot/Serial Number: All Lots. Sold: United States nationwide. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution
- Model: EAN 616612785503, SKU: 1000
- Lot/Serial Number: All Lots
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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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