Vivoo Sodium, Vitamin C, and Hydration test strips sold before legal approval may give false results, leading to wrong medical decisions. Affected units include specific lot numbers from 2024-2025.
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.
Vivoo's Sodium, Vitamin C, and Hydration test strips were recalled because they were distributed before receiving U.S. medical device approval. These tests could give false results, potentially causing incorrect medical treatments if used by non-professionals.
These test strips were sold without proper U.S. medical device approval. They may produce inaccurate results when used by non-professionals, which could lead to wrong medical actions if someone relies on the test outcomes.
People who used Vivoo test strips for home blood tests before 2026 may be affected. Those with health conditions requiring accurate testing are at higher risk.
Check for lot numbers like 2024013123 (Sodium), 2024013124 (Vitamin C), or 2024013119 (Hydration) on the packaging. These were sold between January 2024 and May 2025.
Look for lot numbers on the packaging, such as 2024013123 for Sodium tests or 2024013124 for Vitamin C tests.
If you have a test strip with a lot number from the list, stop using it immediately to avoid potential false results.
No, these test strips were distributed before receiving U.S. medical device approval and may give false results, which could lead to inappropriate medical care.
Check the lot number on the packaging. If it matches the listed numbers (e.g., 2024013123), stop using it immediately and do not use it for medical decisions.
The recall record does not specify a return process, so you may need to contact the manufacturer directly for guidance.
We’ve drafted a message you can send Vivoo to request your refund or repair — edit it as you like.
Subject: Recall Z-1267-2026 — Vivoo Vivoo Hello, I own a Vivoo that is covered by recall Z-1267-2026 from Vivoo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
