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
- Hair Mineral Analysis Device
- Model numbers
- EAN: 616612786074, SKU: E190, 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
Hair Mineral Analysis devices are used to assess mineral levels via hair samples. They are marketed to consumers or healthcare providers for diagnostic purposes.
Why This Is Dangerous
The device was distributed without required premarket clearance, creating a regulatory and potential safety compliance risk.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
No injuries reported so far. Consumers should stop use to avoid regulatory or safety uncertainties. The recall affects 19 units distributed nationwide.
Practical Guidance
How to identify if yours is affected
- Confirm you own the device by checking model and lot numbers.
- Review the recall notice and FDA enforcement page linked in the notice.
- Verify the device was distributed in the US nationwide.
Where to find product info
Recall details available on the FDA enforcement page and the manufacturer's recall notice.
What timeline to expect
Refunds or replacements are typically processed within weeks to months depending on manufacturer and program.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- File a complaint with CPSC or appropriate consumer protection agency if the company is unresponsive.
How to prevent similar issues
- Always verify regulatory clearance before using diagnostic devices.
- Choose FDA-cleared or FDA-approved diagnostic tools when possible.
- Keep records of model numbers, lot codes, and purchase dates for recalls.
Documentation advice
Maintain the recall notice, serial numbers, model numbers, and any correspondence with the manufacturer; keep receipts if applicable.
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Product Details
Brand: GET TESTED INTERNATIONAL AB Product: Hair Mineral Analysis device Models: EAN 616612786074; SKU E190; UDI-DI: None; Lot/Serial Number: All Lots Sold: Nationwide in the United States Recall date: 2025-11-03 Report date: 2025-12-10 Quantity recalled: 19 units Price: Unknown Manufacturer country: Unknown Status: ACTIVE Source: FDA enforcement page linked to recall Z-0783-2026
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Quantity recalled: 19 units
- Brand: GET TESTED INTERNATIONAL AB
- Model numbers: EAN 616612786074; SKU E190; UDI-DI None; Lot/Serial: All Lots
- Hazard: Distribution without premarket approval/clearance
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Safety Guide
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