LH One Step Ovulation Test Device (Urine)
Pending LLM rewrite. Source: FDA_DEVICE Z-1259-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- LH One Step Ovulation Test Device (Urine)
- Manufacturer
- Changchun Wancheng Bio-Electron Co., Ltd.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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