GET TESTED INTERNATIONAL AB recalled 184 units of Menopause (FSH) 2 Tests on November 3, 2025. This recall occurred due to distribution without premarket approval or clearance. Healthcare providers and patients must stop using the tests immediately and follow 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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The recalled product is the Menopause (FSH) 2 Tests, with model numbers EAN: 7340221700437 and SKU: A-FSH. The recall affects 184 units distributed nationwide in the United States.
The tests were distributed without the necessary premarket approval or clearance from the FDA. This lack of approval raises concerns about the safety and efficacy of the product.
No specific incidents or injuries have been reported related to this recall. The risk level is classified as high due to the regulatory issue.
Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by the manufacturer and contact GET TESTED INTERNATIONAL AB or your healthcare provider for further guidance.
For more information, contact GET TESTED INTERNATIONAL AB or visit the FDA recall site at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0744-2026.
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