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
- Iodine test device
- Model numbers
- EAN: 616612785572, SKU: 1JO, 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 product is an iodine test device used in healthcare settings. It is distributed nationwide in the United States by GET TESTED INTERNATIONAL AB.
Why This Is Dangerous
The risk arises from distribution without premarket approval or clearance, which may indicate unknown safety and effectiveness concerns for patients.
Industry Context
This recall is not described as part of a broader industry pattern in the supplied information.
Real-World Impact
Consumers and clinicians must halt use and follow recall instructions to avoid potential unverified risks from an unapproved device.
Practical Guidance
How to identify if yours is affected
- Check if your device has EAN 616612785572 or SKU 1JO.
- Verify the lot/serial number status: All Lots are affected.
- Consult your healthcare provider if you are unsure.
Where to find product info
Refer to the FDA recall page for official instructions and contact information.
What timeline to expect
Refund or replacement processing timelines are determined by the manufacturer after recall validation; typical timelines may vary.
If the manufacturer is unresponsive
- Escalate to patient advocacy groups or regulatory bodies if the manufacturer is unresponsive
- Document all communications and dates
How to prevent similar issues
- Validate PMA/clearance status before marketing a medical device
- Check that products have up-to-date regulatory approvals
- Verify recalls on FDA/official recall databases before clinical use
Documentation advice
Keep copy of recall notices, product packaging, photos of labeling, and all correspondence with manufacturer
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Product Details
Model numbers: EAN 616612785572; SKU 1JO; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the United States. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Hazard level: HIGH
- Brand: GET TESTED INTERNATIONAL AB
- Model identifiers: EAN 616612785572; SKU 1JO; Lot/Serial: 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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