Changchun Wancheng Bio-Electron Co. recalled 1,000 LH One Step Ovulation Test Devices on November 22, 2025. The tests may deliver false or inaccurate results, potentially leading to inappropriate medical intervention. The recall affects U.S. consumers in Texas, Georgia, and California.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Changchun Wancheng Bio-Electron Co., Ltd. or your healthcare provider for instructions. Notification method: Letter
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The LH One Step Ovulation Test Device is designed to help individuals track their ovulation cycle. It is commonly used by those trying to conceive to identify fertile windows.
The devices were distributed without proper regulatory approval, which raises concerns about their accuracy. Inaccurate results could mislead users and lead to inappropriate medical actions.
This recall is not part of a broader industry pattern.
Consumers may face inconvenience and potential health risks due to reliance on inaccurate test results.
Serial numbers and lot information are typically located on the packaging or user manual.
Expect a refund processing time of approximately 4-6 weeks after submission of your request.
Keep all receipts, correspondence with the manufacturer, and photographs of the product as evidence.
The LH One Step Ovulation Test Device (Urine), model GT-LH 20251601, was distributed nationwide. The affected lot has an expiration date of May 2027.
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