FDA-Device2025-12-10Class IIMISBRANDING

Menopause (FSH) 2 Tests

FALSE CLAIMSNationwide distributiondevice
Hazard

Distribution without premarket approval/clearance.

Who it affects
Adults (40 years and older)
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
184 units
Manufactured in
59334 Vastervik, Lysingsvagen 18, Vastervik, Sweden
Products
Menopause (FSH) 2 Tests

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0744-2026

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