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 (Urine), model GT-LH 20251601, was distributed nationwide. The affected lot has an expiration date of May 2027.
These devices may generate inaccurate test results. This can mislead users into making incorrect health decisions.
No specific incidents or injuries have been reported at this time. The recall arises from regulatory compliance issues.
Stop using the ovulation test immediately. Consumers should follow recall instructions provided by the manufacturer.
For further information, contact Changchun Wancheng Bio-Electron Co., Ltd. or consult your healthcare provider.
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