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
- HPV Antigen Test
- Model numbers
- EAN: 7340221708259, SKU: A-HPV, 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
The HPV Antigen Test is a medical device used to detect the presence of human papillomavirus (HPV). Consumers typically purchase this test for screening purposes in a healthcare setting or at home.
Why This Is Dangerous
The hazard arises from the distribution of the HPV Antigen Test without the necessary premarket approval, which raises concerns about its reliability and safety for consumer use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects the availability of HPV testing options for consumers, potentially leading to delays in necessary health screenings.
Practical Guidance
How to identify if yours is affected
- Check the model number on your HPV Antigen Test package.
- Verify if it matches EAN: 7340221708259 or SKU: A-HPV.
- Confirm the lot number; all lots are affected.
Where to find product info
Model numbers and lot information can typically be found on the packaging or the product insert.
What timeline to expect
Refund processing typically takes 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Document your communication attempts with the manufacturer.
- Contact the FDA if the manufacturer is unresponsive.
How to prevent similar issues
- Always ensure that medical devices are FDA-approved before use.
- Consult with healthcare providers for recommendations on safe testing options.
- Be cautious of devices without clear regulatory approval.
Documentation advice
Keep records of your purchase, correspondence with the manufacturer, and any receipts or invoices as documentation.
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Product Details
The recalled product is the HPV Antigen Test, with model numbers including EAN: 7340221708259 and SKU: A-HPV. The recall affects all lots of this product. It was distributed nationwide in the United States.
Key Facts
- Recalled product: HPV Antigen Test
- Manufacturer: GET TESTED INTERNATIONAL AB
- Recall date: November 3, 2025
- Total units recalled: 258
- Distribution: Nationwide in the U.S.
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Safety Guide
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