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
- Serotonin Test Kit
- Model numbers
- EAN: 616612785718, SKU: 1SE, 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
Serotonin tests measure serotonin levels for diagnostic or research purposes. They are used by healthcare providers in clinical settings.
Why This Is Dangerous
The device was distributed without required premarket approval or clearance, which may affect regulatory safety compliance for clinical use.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
No injuries reported. Affects 12 units; requires immediate cessation of use and adherence to manufacturer instructions.
Practical Guidance
How to identify if yours is affected
- Verify model number and lot information: EAN 616612785718, SKU 1SE, All Lots.
- Check label and packaging for GET TESTED INTERNATIONAL AB branding.
- Confirm distribution was nationwide in the United States.
Where to find product info
Recall notification letters or the manufacturer’s guidance; FDA recall page for Z-0815-2026.
What timeline to expect
Not specified by the manufacturer. Expect further instructions from GET TESTED INTERNATIONAL AB.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- File a complaint with CPSC if the company remains unresponsive.
- Consult your healthcare provider for alternatives.
How to prevent similar issues
- Verify regulatory clearance before purchasing diagnostic devices.
- Check FDA recall database before using new medical devices.
- Be cautious of devices without clear PMA/510(k) history.
Documentation advice
Keep the recall letter, packaging, and purchase details. Save all correspondence with the manufacturer.
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Product Details
Model numbers: EAN 616612785718; SKU 1SE; UDI-DI: None; Lot/Serial Number: All Lots. Sold nationwide in the United States. Recall date: 2025-11-03. Manufacturer: GET TESTED INTERNATIONAL AB. Categories: Health & Personal Care; Medical Devices. Quantity recalled: 12 units. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model numbers: EAN 616612785718; SKU 1SE; UDI-DI: None; Lot/Serial Number: All Lots
- Nationwide distribution in the United States
- Hazard: Distribution without premarket approval/clearance
- Remedy: Stop using and contact GET TESTED INTERNATIONAL AB for instructions
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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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