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

Source: FDA · United States

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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 February 19, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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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 ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Changchun Wancheng Bio-Electron Co., Ltd. is recalling 1,000 Menopause Test Cassettes distributed without FDA clearance, posing a risk of inaccurate diagnostic results.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.