Reason for Recall
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
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customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Recall NumberZ-1267-2026ClassificationClass IIStatusOngoingCategorydeviceInitiated2025-11-22Reported2026-02-11DistributionUS Nationwide distribution in the states of TX, GA, CA.Code InfoName/Lot(Expiration): Vivoo Sodium Test/2024013123(01/30/2026); Vivoo Vitamin C Test/2024013124(01/30/2026); Vivoo Hydration Test/2024013119(01/30/2026), 2025051519(05/14/2027)Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.