Changchun Wancheng Bio-Electron Recalls Vivoo Protein Test Strips Over Marketing Clearance Issues

Source: FDA · United States

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Changchun Wancheng Bio-Electron Co., Ltd. is recalling 500 Vivoo Protein Test units because they were distributed without required FDA marketing clearance, posing a risk of inaccurate results.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on February 18, 2026 and geographically references United States. Its severity classification of "high" 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 Vivoo Protein Test strips. The recall was prompted because the test strips and associated near-patient testing components were distributed to U.S. customers before they could be legally marketed through the required 510(k) clearance process. There is a concern that these devices may produce false or inaccurate diagnostic results when used by laypersons, which could lead to inappropriate medical interventions.

Which Products Are Affected

The recall involves 500 units of the following product:

  • Product Name: Vivoo Protein Test
  • Lot Number: 2024013122
  • Expiration Date: 01/30/2026
  • Recall Number: Z-1265-2026

The affected products were distributed nationwide in the United States, with specific distribution noted in Texas, Georgia, and California.

What You Should Do

Consumers who possess the Vivoo Protein Test from the affected lot should immediately discontinue use of the product. The recalling firm, Changchun Wancheng Bio-Electron Co., Ltd., initiated the recall process on November 22, 2025, via notification letters. Consumers should contact the firm or their point of purchase for further instructions regarding the return or disposal of these unapproved medical devices.

Why This Matters

The use of diagnostic tests that have not been cleared by the FDA poses a significant risk to public health, as inaccurate results can lead to incorrect self-diagnosis and potentially dangerous medical decisions based on faulty data.

Source

Information provided by the U.S. Food and Drug Administration (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 500 Vivoo Protein Test units because they were distributed without required FDA marketing clearance, posing a risk of inaccurate 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 "high" severity. Take precautions and monitor for updates.
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.