Changchun Wancheng Bio-Electron Recalls Menopause Test Cassettes Over Regulatory Concerns

What Happened

Changchun Wancheng Bio-Electron Co., Ltd. has initiated a voluntary recall of its Menopause Test Cassette (Urine) products. The recall was triggered because the test strips were distributed to U.S. customers before they could be legally marketed through the required 510(k) clearance process. According to the FDA, these devices may produce false or inaccurate diagnostic results when used by a layperson, which could lead to inappropriate medical interventions.

Which Products Are Affected

The recall involves 1,000 units of the following product:

• Product Name: Menopause Test Cassette (Urine)
• Lot Number: GT-FSH 20251601
• Expiration Date: 05-2027
• Recall Number: Z-1260-2026

The products were distributed nationwide in the United States, specifically within the states of Texas (TX), Georgia (GA), and California (CA).

What You Should Do

Consumers and healthcare providers in possession of the affected lots should stop using the tests immediately. The firm initiated the notification process via letter on November 22, 2025. For information regarding returns, refunds, or disposal instructions, consumers should contact Changchun Wancheng Bio-Electron Co., Ltd. directly at their headquarters in Changchun, China.

Why This Matters

Using a diagnostic medical device that has not undergone regulatory review increases the risk of receiving incorrect health information. Inaccurate results regarding menopause status could lead individuals to make incorrect decisions about their reproductive health or hormonal treatments.

Source

Information provided by the FDA.