Menopause Test Cassette (Urine)
FDA Recall #Z-1260-2026 — Class II — November 22, 2025
Product Description
Menopause Test Cassette (Urine)
Reason for Recall
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Recalling Firm
Changchun Wancheng Bio-Electron Co., Ltd. — Changchun, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,000
Distribution
US Nationwide distribution in the states of TX, GA, CA.
Code Information
Name/Lot(Expiration): Menopause Test Cassette (Urine)/GT-FSH 20251601(05-2027)
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated