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
- 3 in 1 STI Test Kit
- Model numbers
- EAN: 7340221704770, SKU: JD-3STI, 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
This is a at-home diagnostic test marketed as a 3-in-1 STI test kit. Consumers purchase it for quick screening for multiple sexually transmitted infections.
Why This Is Dangerous
The hazard arises from distributing a diagnostic device without proper regulatory clearance. The device may not have been evaluated for safety and effectiveness.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
Consumers may experience delays in obtaining regulated testing or may seek alternative testing options until proper clearance is secured.
Practical Guidance
How to identify if yours is affected
- Check packaging for brand name Get Tested International AB and the product name 3 in 1 STI Test.
- Look for model identifiers: EAN 7340221704770, SKU JD-3STI, Lot/Serial Number: All Lots.
- Verify recall status via the FDA enforcement page.
Where to find product info
Recall notices and model identifiers are typically listed on the packaging, the manufacturer’s site, and the FDA recall page.
What timeline to expect
Refund or replacement processing often takes several weeks; exact timelines are provided by the manufacturer.
If the manufacturer is unresponsive
- Escalate to consumer protection agencies if the manufacturer is unresponsive.
- Consult the FDA MedWatch or equivalent for reporting concerns.
How to prevent similar issues
- Buy tests only from trusted retailers; verify regulatory clearance status before use.
- Check recall databases before using at-home diagnostic tests.
- Keep records of purchases and recall notices for documentation.
Documentation advice
Save purchase receipts, recall notices, and all correspondence with the manufacturer. Take photos of the product packaging and serial numbers.
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Product Details
Brand: Get Tested International AB Product: 3 in 1 STI Test Model numbers: EAN 7340221704770; SKU JD-3STI; UDI-DI: None; Lot/Serial Number: All Lots Sold nationwide in the United States Quantity recalled: 1,210 units Recall date: 2025-11-03 Status: ACTIVE Category: Health & Personal Care, Medical Devices
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Nationwide distribution in the U.S.
- Hazard: distribution without premarket approval/clearance
- Model numbers include EAN 7340221704770 and SKU JD-3STI
- Recall date 2025-11-03; status ACTIVE
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Safety Guide
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