Changchun Wancheng Bio-Electron Co. recalled 500 Vivoo Protein Test strips on November 22, 2025. The devices may provide false diagnostic results, leading to inappropriate medical interventions. This recall affects consumers nationwide in Texas, Georgia, and California.
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Changchun Wancheng Bio-Electron Co., Ltd. or your healthcare provider for instructions. Notification method: Letter
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The Vivoo Protein Test is a diagnostic tool used to measure protein levels in urine, which can indicate various health conditions. Consumers typically purchase this product for at-home health monitoring and to assist in managing health conditions.
The Vivoo Protein Test may provide inaccurate results due to the lack of proper FDA approval, potentially leading to incorrect health assessments. This risk is especially concerning for individuals managing health conditions that require accurate monitoring.
This recall is not part of a broader industry pattern.
Consumers may face significant health risks if they rely on inaccurate results from the Vivoo Protein Test, leading to possible inappropriate medical interventions.
Look for the model name and expiration date on the box or the label of the test strips.
Expect processing for refunds to take approximately 4-6 weeks after returning the product.
Keep records of your purchase, including receipts and any correspondence with the manufacturer.
The recalled product is the Vivoo Protein Test, model name Vivoo Protein Test/2024013122, with an expiration date of January 30, 2026. The tests were distributed nationwide in the United States, specifically in Texas, Georgia, and California.
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