Changchun Wancheng Bio-Electron Co. recalled 3,300 Vivoo test strips on November 22, 2025. The devices may provide inaccurate results, leading to inappropriate medical actions. Affected products include sodium, Vitamin C, and hydration tests.
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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Vivoo test strips are used for at-home health monitoring, allowing consumers to test sodium, Vitamin C, and hydration levels. They appeal to health-conscious individuals looking for convenient health management solutions.
The recall stems from the distribution of test strips that lacked proper FDA approval, which can result in misleading health information for users. This may lead to unnecessary medical actions or treatments based on incorrect results.
This recall is not part of a broader industry pattern.
Consumers may face health risks by relying on these inaccurate test results, potentially leading to misdiagnosis or inappropriate treatment.
The model numbers and expiration dates can typically be found on the packaging or the test strip container itself.
Expect processing for refunds or replacements to take approximately 4-6 weeks.
Keep all receipts, correspondence with the manufacturer, and any documentation related to the recall for your records.
The recall involves the Vivoo Sodium Test, Vivoo Vitamin C Test, and Vivoo Hydration Test. These products were distributed nationwide in Texas, Georgia, and California. They were not legally marketed in the U.S. before distribution.
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