Changchun Wancheng Bio-Electron Recalls Vivoo Protein Test Strips Over Marketing Clearance Issues
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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 April 6, 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 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, MedicalDevice.
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 ↗
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