Changchun Wancheng Bio-Electron Co., Ltd. recalls Vivoo pH Test strips due to potential false results from unapproved devices, risking incorrect medical decisions. Affected units sold before legal market approval.
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.
Changchun Wancheng Bio-Electron Co., Ltd. recalled Vivoo pH Test strips because they were distributed before getting U.S. regulatory approval. These tests may give false results, leading to wrong medical actions by non-professionals.
The Vivoo pH Test strips were sold without U.S. regulatory approval. This means they might not work correctly, causing false results that could lead to incorrect medical treatments if used by non-professionals.
People who bought Vivoo pH Test strips before January 30, 2026, for home use. Those with health conditions requiring accurate pH testing are most at risk.
Check for the label 'Vivoo pH Test/2024013121' with an expiration date of January 30, 2026. These strips were sold before receiving U.S. market approval.
Look for the label 'Vivoo pH Test/2024013121' with an expiration date of January 30, 2026.
The Vivoo pH Test strips were distributed before getting U.S. regulatory approval, which may cause false results and lead to inappropriate medical actions.
Check for the label 'Vivoo pH Test/2024013121' with an expiration date of January 30, 2026.
The recall record does not specify a remedy, so contact the manufacturer 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-1264-2026 — Vivoo Vivoo Hello, I own a Vivoo that is covered by recall Z-1264-2026 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.
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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.
