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
- 8 in 1 STI Test Kit
- Model numbers
- EAN: 7340221704794, SKU: JD-8STI, 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 at-home diagnostic test kit marketed as an 8-in-1 STI test. It is distributed nationwide in the United States.
Why This Is Dangerous
The recall concerns distribution without FDA premarket approval or clearance. This regulatory issue can affect test accuracy and consumer safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may rely on test results that were not regulated for accuracy. There is potential for confusion and questions about liability, with no reported injuries in the notice.
Practical Guidance
How to identify if yours is affected
- Check model numbers: EAN 7340221704794 and SKU JD-8STI.
- Confirm lot/serial number: All lots are included in the recall.
- If your kit matches these identifiers, proceed with recall steps.
Where to find product info
Refer to FDA enforcement report Z-0818-2026 and the manufacturer communications for official guidance.
What timeline to expect
The recall notice does not specify a refund or replacement timeline.
If the manufacturer is unresponsive
- Document all contact attempts with GET TESTED INTERNATIONAL AB.
- If the company does not respond within a reasonable period, file a report with the FDA.
- Consult your healthcare provider for safe alternative testing options.
How to prevent similar issues
- Verify regulatory clearance before purchasing any at-home diagnostic kit.
- Prefer products with clear FDA clearance or FDA-approved status.
- Buy from reputable brands with transparent recall and support channels.
Documentation advice
Keep the recall notice, purchase receipts, product packaging, and all correspondence with the manufacturer as records.
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Product Details
Model numbers: EAN 7340221704794, SKU JD-8STI. UDI-DI: None. Lot/Serial Number: All Lots. Sold Nationwide in the United States. Quantity: 2,043 units.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model JD-8STI; EAN 7340221704794
- All Lots affected
- FDA enforcement reference Z-0818-2026
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Safety Guide
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