Vivoo Sodium, Vitamin C, and Hydration Test Strips Recalled for Inaccurate Results
What this means
Vivoo urine test strips for sodium, vitamin C, and hydration were sold without required FDA approval and may provide false or inaccurate results. These tests are designed for home use and incorrect results could lead to unnecessary medical decisions. The affected products have specific lot numbers and expiration dates in 2026 and 2027.
- Do not use Vivoo Sodium Test (lot 2024013123), Vitamin C Test (lot 2024013124), or Hydration Test (lots 2024013119 or 2025051519)
- Discard the test strips or contact Vivoo for instructions on returns
- Do not rely on results from these tests for any health decisions
- Consult your doctor if you made medical decisions based on these tests
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1267-2026Want us to check the next one for you?
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