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Z-1259-2026Class II

Changchun Wancheng Bio-Electron Co., Ltd.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Changchun Wancheng Bio-Electron Co., Ltd.
Product type
Device
Status
Ongoing
Report date
2026-02-11
Distribution
US Nationwide distribution in the states of TX, GA, CA.
Firm state
N/A
Product quantity
1,000
Initiated by
Voluntary: Firm initiated
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.

Product description

LH One Step Ovulation Test Device (Urine)

Code / lot info

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

Other recalls SPEQ maps to Documentation & Change Control
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Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →