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Recall Observatory FDA recall evidence

Device product

LH One Step Ovulation Test Device (Urine)

Z-1259-2026

November 22, 2025

Class II

Product summary

Firm
Changchun Wancheng Bio-Electron Co., Ltd.
Event
Event 97801
Status
Ongoing
Classification
Class II
Quantity
1,000
Official record key
device-enforcement:Z-1259-2026

Official wording

Reason: 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.

Code information: Name/Lot(Expiration): LH One Step Ovulation Test Device (Urine)/GT-LH 20251601(05-2027)

Distribution pattern: US Nationwide distribution in the states of TX, GA, CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.