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
- Neurotransmitters Device
- Model numbers
- EAN: 616612786449, SKU: F510, 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
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
Neurotransmitters Plus is a medical device used for health monitoring. Consumers typically purchase it for evaluating neurotransmitter levels and related health assessments.
Why This Is Dangerous
The device poses a risk because it was distributed without the necessary regulatory approval, which can lead to potential health risks from unverified claims or effectiveness.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers face potential health risks from using an unapproved medical device, necessitating immediate cessation of use and return of the product.
Practical Guidance
How to identify if yours is affected
- Check if you have the Neurotransmitters Plus device in your possession.
- Verify the model numbers: EAN: 616612786449 and SKU: F510.
- Confirm that you received a notification letter regarding the recall.
Where to find product info
Look for the model number on the device packaging or any accompanying documentation.
What timeline to expect
Expect processing for returns and refunds to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all correspondence with GET TESTED INTERNATIONAL AB.
- Follow up via phone or email if you do not receive a response within a week.
- Consider filing a complaint with the FDA if issues persist.
How to prevent similar issues
- Always check for FDA approval before purchasing medical devices.
- Research product reviews and recall history for safety records.
- Consult healthcare providers for device recommendations.
Documentation advice
Keep a record of your purchase receipt, any communication regarding the recall, and photographs of the product.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled product is Neurotransmitters Plus. The affected model numbers include EAN: 616612786449 and SKU: F510. The product had nationwide distribution across the United States.
Key Facts
- Distributed without premarket approval
- High hazard level
- Immediate stop-use recommended
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.