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
- HSV Test Kit
- Model numbers
- EAN: 7340221710047, SKU: A-HSV, 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
HSV-1/HSV-2 tests diagnose herpes infections. Some kits are marketed for home or clinical use. The recall concerns regulatory clearance for this product.
Why This Is Dangerous
Distribution without premarket approval suggests the device may not have been evaluated for safety and effectiveness by the FDA. The lack of clearance raises concerns about accuracy and reliability.
Industry Context
This recall is not identified as part of a broader industry pattern in the provided data.
Real-World Impact
Consumers may be using a test that lacks regulatory clearance, potentially leading to inaccurate results and inappropriate clinical decisions.
Practical Guidance
How to identify if yours is affected
- Verify model numbers: EAN 7340221710047 or SKU A-HSV.
- Note: All lots are affected.
- Check packaging for the warning and recall notice.
Where to find product info
FDA recall page at the provided enforcement URL and manufacturer communications.
What timeline to expect
Refund or replacement, if offered, typically takes several weeks; expect 4-6 weeks for processing in many recalls.
If the manufacturer is unresponsive
- File a consumer complaint with the FDA or CPSC if the company is unresponsive.
- Consult a healthcare provider for guidance on testing alternatives.
How to prevent similar issues
- Only purchase FDA-cleared HSV tests from reputable sources.
- Verify premarket approval status before purchase.
- Use tests from manufacturers with active regulatory clearances.
- Keep recall notices and documentation for records.
Documentation advice
Retain recall notice, packaging, purchase receipts, and all correspondence with the company.
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Product Details
Brand: Get Tested International AB Product: HSV-1 & HSV-2 Test Kit Model numbers: EAN 7340221710047, SKU A-HSV UDI-DI: None Lot/Serial Number: All Lots Quantity: 1361 units Sold in: United States nationwide distribution Sold by: Unknown Price: Unknown Date sold: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Class II recall
- Distribution without premarket approval/clearance
- Model: EAN 7340221710047; SKU: A-HSV
- All lots affected
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Safety Guide
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