Changchun Wancheng Bio-Electron Recalls Menopause Test Cassettes Over Regulatory Concerns
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Changchun Wancheng Bio-Electron Co., Ltd. is recalling 1,000 Menopause Test Cassettes distributed without FDA clearance, posing a risk of inaccurate diagnostic results.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
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.
Original source: FDA Official Notice ↗
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