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 Testing Device
- Model numbers
- EAN: 7340221707221, SKU: HT-IgE, 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 Allergy Test IgE is designed to detect specific IgE antibodies associated with allergic reactions. Consumers may purchase this test to identify potential allergens affecting their health.
Why This Is Dangerous
The hazard arises from distributing the Allergy Test IgE without premarket approval, meaning it has not been evaluated for safety and effectiveness by regulatory authorities.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers using this device may face potential health risks due to the lack of safety evaluation, which can lead to misdiagnosis or ineffective allergy management.
Practical Guidance
How to identify if yours is affected
- Check if you have the Allergy Test IgE with SKU HT-IgE or EAN 7340221707221.
- Verify if you received any communication regarding the recall from your healthcare provider or the manufacturer.
- If you are unsure, contact GET TESTED INTERNATIONAL AB for clarification.
Where to find product info
Serial numbers, lot numbers, and other identifiers can usually be found on the product packaging or accompanying documentation.
What timeline to expect
Expect a response regarding refunds or further instructions within 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Document your communication attempts with GET TESTED INTERNATIONAL AB.
- Consider reaching out to the FDA for further assistance if the company is unresponsive.
How to prevent similar issues
- Always check for FDA approval before using medical devices.
- Research manufacturers and their compliance with health regulations.
- Consult healthcare providers for recommended allergy testing methods.
Documentation advice
Keep records of your purchase, communication with the manufacturer, and any health symptoms related to the use of the device.
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Product Details
The Allergy Test IgE carries the SKU HT-IgE and EAN 7340221707221. It has no specific UDI-DI and all lots are affected. The product was distributed nationwide across the United States.
Key Facts
- 71 units recalled nationwide
- Class II recall due to distribution issues
- Immediate discontinuation of use recommended
- No reported injuries or incidents
- Contact GET TESTED INTERNATIONAL AB for instructions
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Safety Guide
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