Changchun Wancheng Bio-Electron Co., Ltd. recalls LH One Step Ovulation Test Device
- Recalling company
- Changchun Wancheng Bio-Electron Co., Ltd.
- Product
- LH One Step Ovulation Test Device (Urine)
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Nov 22, 2025
- Reported
- Feb 11, 2026
- Distribution
- US Nationwide distribution in the states of TX, GA, CA.
- Status
- Ongoing
- Quantity
- 1,000
- Lot / codes
- Name/Lot(Expiration): LH One Step Ovulation Test Device (Urine)/GT-LH 20251601(05-2027)
- Company location
- Changchun, N/A
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1259-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1259-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.