Changchun Wancheng Bio-Electron Co. recalled 1,000 Menopause Test Cassettes on November 22, 2025. The recall follows reports that the devices can produce false or inaccurate results, potentially leading to inappropriate medical interventions. Customers in Texas, Georgia, and California should stop using the test immediately and follow recall instructions.
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 Menopause Test Cassette (Urine) is designed to help women self-test for menopause indicators. Consumers purchase these tests for convenience and privacy in managing their health.
The hazard arises from the lack of proper FDA clearance, leading to false or inaccurate test results that could mislead users regarding their health status.
This recall is not part of a broader industry pattern.
This recall poses a high risk for consumers who may rely on these results for health decisions, potentially leading to inappropriate medical interventions.
The model number and expiration date are typically located on the packaging or the test cassette itself.
Expect processing for refunds or replacements to take 4-6 weeks after returning the product.
Keep a copy of the recall notice, any correspondence with the manufacturer, and receipts for your records.
The recalled product is the Menopause Test Cassette (Urine), model GT-FSH 20251601 with an expiration date of May 2027. The product was distributed nationwide in the U.S., specifically in Texas, Georgia, and California.
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