Quick Facts at a Glance
- Recall Date
- November 3, 2025
- Hazard Level
- HIGH
- Brand
- GET TESTED INTERNATIONAL AB
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- FSH Test Kit
- Model numbers
- EAN: 7340221700437, SKU: A-FSH, UDI-DI: None, Lot/Serial Number: All Lots
- Sold at
- Unknown
- 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 product is a diagnostic test kit described as Menopause (FSH) 2 Tests. It is marketed for measuring follicle-stimulating hormone levels to assess menopausal status. Users include adults seeking hormonal information for menopause-related questions.
Why This Is Dangerous
The hazard arises from distribution of a diagnostic device without FDA premarket approval or clearance. This creates potential regulatory and safety concerns due to lack of review and labeling validation.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers who own this kit may be uncertain about regulatory status and test validity. The recall creates urgency to stop use and verify status with the manufacturer or healthcare provider.
Practical Guidance
How to identify if yours is affected
- Check if you own a GET TESTED INTERNATIONAL AB Menopause FSH Test Kit.
- Look for EAN 7340221700437 or SKU A-FSH.
- Note that all lots are affected.
- Compare packaging to the recall notice for any identifying markers.
- If affected, stop use immediately and follow recall instructions.
Where to find product info
Recall notices and enforcement details are available on the FDA recall page and the manufacturer9;s communications.
What timeline to expect
Refunds or replacements are handled per manufacturer instructions. Expect several weeks for processing.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- File a complaint with the FDA recall program if the company is unresponsive.
- Consult a healthcare provider for alternative testing options.
How to prevent similar issues
- Verify FDA premarket clearance or authorization status before purchasing diagnostic tests.
- Check for the recall number and model information on the packaging before use.
- Source tests from reputable manufacturers with clear regulatory approvals.
Documentation advice
Keep the recall letter, packaging, purchase receipts, and any correspondence with the manufacturer. Document test results and symptoms if any.
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Product Details
Model numbers: EAN 7340221700437; SKU: A-FSH; UDI-DI: None; Lot/Serial Number: All Lots. Sold at: US nationwide distribution. When sold: Unknown. Price: Unknown. Recall date: 2025-11-03. Manufacturer: GET TESTED INTERNATIONAL AB. Classification: Class II.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution
- Model numbers include EAN 7340221700437 and SKU A-FSH
- All lots affected
- No injuries reported
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