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Changchun Wancheng Bio-Electron Co., Ltd.: LH One Step Ovulation Test Device (Urine)

Medical DevicesSource: FDA (device) · Date: 2026-02-11

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Changchun Wancheng Bio-Electron Co., Ltd.
Product
LH One Step Ovulation Test Device (Urine)
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of TX, GA, CA.
Recall initiated
2025-11-22
Code info
Name/Lot(Expiration): LH One Step Ovulation Test Device (Urine)/GT-LH 20251601(05-2027)
Product quantity
1,000
Voluntary mandated
Voluntary: Firm initiated
City
Changchun
State
N/A
Country
China
Event id
97801
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