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
- Medical Device
- Model numbers
- EAN: 7340221701083, SKU: A-DR12, 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
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
This product is a medical device intended for health monitoring or diagnostic use. Consumers may purchase such devices for personal health management or medical needs.
Why This Is Dangerous
The hazard arises from the product's distribution without the required premarket approval, meaning it has not been evaluated for safety or effectiveness by regulatory authorities.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face health risks from using this unapproved device, leading to potential misdiagnosis or ineffective treatment options.
Practical Guidance
How to identify if yours is affected
- Check the EAN: 7340221701083 or SKU: A-DR12 to determine if your device is affected.
- Review any communication from GET TESTED INTERNATIONAL AB regarding the recall.
- Confirm that the device was distributed without proper clearance.
Where to find product info
The EAN is typically found on the product packaging or the device itself, often near the barcode.
What timeline to expect
Refund or replacement processing timelines may vary; expect 4-8 weeks for resolution.
If the manufacturer is unresponsive
- Document your communication attempts with the manufacturer.
- Contact regulatory authorities for further guidance if the company is unresponsive.
How to prevent similar issues
- Always verify that medical devices are FDA-approved before purchase.
- Look for devices with clear regulatory compliance markings.
- Consult healthcare professionals for recommendations on approved devices.
Documentation advice
Keep all correspondence regarding the recall, including letters and emails, as well as any receipts or proof of purchase.
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Product Details
The recalled product is identified by EAN: 7340221701083 and SKU: A-DR12. It has no specific lot or serial number as all lots are affected. The product was distributed nationwide in the United States.
Key Facts
- Recalled on November 3, 2025
- One unit affected
- Illegal marketing due to lack of premarket approval
- Contact GET TESTED INTERNATIONAL AB for instructions
- Nationwide distribution in the United States
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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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