GET TESTED INTERNATIONAL AB recalled 184 Menopause (FSH) 2 Tests distributed nationwide in the United States. The tests were distributed without premarket approval or clearance. Patients and healthcare providers should stop using the device immediately and follow the recall instructions.
Distribution without premarket approval/clearance.
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
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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.
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.
This recall is not described as part of a broader industry pattern.
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.
Recall notices and enforcement details are available on the FDA recall page and the manufacturer9;s communications.
Refunds or replacements are handled per manufacturer instructions. Expect several weeks for processing.
Keep the recall letter, packaging, purchase receipts, and any correspondence with the manufacturer. Document test results and symptoms if any.
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.
No injuries or incidents have been reported.
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