Changchun Wancheng Bio-Electron Co., Ltd. recalls Vivoo Vaginal pH Test strips due to potential false results from unapproved devices, which could lead to incorrect medical decisions. Affected units sold before legal marketing in the U.S.
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 Vaginal pH Test strips because they were distributed before being legally approved for U.S. use. This could cause false test results, leading to inappropriate medical treatments if users rely on the device.
The Vivoo test strips were distributed before receiving U.S. regulatory approval. This means they may not work correctly, potentially giving false results that could lead to unnecessary medical procedures or missed treatments.
Women who purchased Vivoo Vaginal pH Test strips before March 21, 2026, are likely affected. Those using the device for self-testing without medical supervision face the highest risk of incorrect results.
Check for the lot number 2024032219 on the Vivoo Vaginal pH Test packaging. These strips were sold before March 21, 2026, and were distributed in the U.S. without proper regulatory approval.
Look for the lot number 2024032219 on the Vivoo Vaginal pH Test packaging to confirm if it's affected.
The Vivoo Vaginal pH Test strips were distributed before receiving U.S. regulatory approval, which could lead to false results and inappropriate medical interventions.
Check for the lot number 2024032219 on the Vivoo Vaginal pH Test packaging. These strips were sold before March 21, 2026.
The recall record does not specify a remedy, so 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-1266-2026 — Vivoo Vivoo Hello, I own a Vivoo that is covered by recall Z-1266-2026 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.
