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

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).