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Open, Classified

Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test

FDA Recall Z-1267-2026 · Posted 2026-02-04

Recall StatusOpen, Classified
Product CodeJJW
Date Initiated2025-11-22
Product Quantity3,300

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. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

Firm Action

Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following: 1) Destroy unused devices. 2) Inform customers that test results may be inaccurate, and it is recommended to re-test. 3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall. 4) Complete and return the Acknowledgement and Receipt Form via email to: [email protected] Questions can be emailed to the firm at: [email protected] / [email protected]

Root Cause

No Marketing Application

Distribution Pattern

US Nationwide distribution in the states of TX, GA, CA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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