Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Ferritin Iron Deficiency Test Device
- Model numbers
- EAN: 616612785589, SKU: 1FE, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Unknown
- 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 ferritin iron deficiency test is intended to measure iron stores in a patient via a laboratory or diagnostic device. Such tests guide clinical decisions about iron supplementation or further testing.
Why This Is Dangerous
Distributing a diagnostic device without FDA premarket approval or clearance may lead to unreliable results and inappropriate clinical decisions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall could affect patient care if unapproved tests yield inaccurate ferritin results. No injuries have been reported yet.
Practical Guidance
How to identify if yours is affected
- Verify model numbers: EAN 616612785589 and SKU 1FE.
- Check Lot/Serial Number: All Lots.
- Confirm distribution was nationwide in the United States.
Where to find product info
Model numbers and lot/serial information should appear on device packaging and accompanying documentation.
What timeline to expect
Timeline for refunds or replacements is not specified in the recall notice.
If the manufacturer is unresponsive
- Escalate to the FDA recall program and seek guidance through safety recalls channels.
- Document all communications with the manufacturer.
How to prevent similar issues
- Only use FDA-cleared ferritin tests or those with proper FDA approval.
- Purchase diagnostic tests from reputable suppliers.
- Verify premarket clearance before using any new diagnostic device.
Documentation advice
Keep the recall notice, packaging, photos of the device, model numbers, and any correspondence with the manufacturer.
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Product Details
Model numbers: EAN 616612785589; SKU 1FE; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the United States. Price: Unknown. Recall date: 2025-11-03. Report date: 2025-12-10.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Brand: GET TESTED INTERNATIONAL AB
- Product: Iron Deficiency Test (ferritin)
- Hazard: Distribution without premarket approval/clearance
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Safety Guide
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