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
- Food Allergy Panel Test (IgE)
- Model numbers
- EAN 7340221709157, SKU U44, 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 Food Allergy Panel Test (IgE) is a diagnostic tool used to screen for multiple food allergies in a single assay. It is distributed by GET TESTED INTERNATIONAL AB and marketed in the United States.
Why This Is Dangerous
The recall revolves around distribution without FDA premarket approval or clearance, meaning the product may not have undergone proper regulatory evaluation for safety and effectiveness.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers who own the kit should halt use and seek guidance from a healthcare professional. The recall could affect diagnostic decision-making if the kit was used to influence care.
Practical Guidance
How to identify if yours is affected
- Check if you own a GET TESTED INTERNATIONAL AB Food Allergy Panel Test (IgE) with EAN 7340221709157 or SKU U44.
- Verify the lot/serial number is All Lots.
- Confirm US nationwide distribution was the channel of purchase.
Where to find product info
Identifiers are on packaging labeling. The EAN is 7340221709157. The SKU is U44. Lot/serial number is All Lots.
What timeline to expect
Refunds or replacements follow the manufacturer recall process. Processing may take 4-6 weeks after verification.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- File a complaint with the FDA if the company is slow to respond.
- Consult a healthcare provider for interim testing options.
How to prevent similar issues
- Before buying diagnostic tests, verify FDA clearance status.
- Look for clear regulatory labeling and manufacturer contact information.
- Avoid unapproved diagnostic devices.
Documentation advice
Keep the recall letter, packaging, photos of labeling, and all correspondence. Save receipts or proof of purchase if available.
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Product Details
Brand: GET TESTED INTERNATIONAL AB Product: Food Allergy Panel Test (IgE) Models: EAN 7340221709157; SKU U44; UDI-DI: None; Lot/Serial Number: All Lots Quantity recalled: 3 units Sold in the U.S.: Nationwide distribution Recall date: 2025-11-03 Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Nationwide U.S. distribution
- Model: EAN 7340221709157, SKU U44
- Lot/Serial Number: All Lots
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Safety Guide
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