Changchun Wancheng Bio-Electron Co., Ltd. recalls Vivoo Protein Test strips due to potential false results from improper use, 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 Protein Test strips because they were distributed before being legally approved for U.S. customers. This could cause false or inaccurate test results, potentially leading to wrong medical treatments.
The test strips were distributed before receiving U.S. regulatory approval. This means they might not work correctly when used by non-experts, causing false results that could lead to unnecessary medical procedures.
People who bought Vivoo Protein Test strips before January 30, 2026, for home use. Those with medical conditions requiring accurate testing are at higher risk.
Check for the lot number 2024013122 on the Vivoo Protein Test strips. These were sold before January 30, 2026, in the U.S. market.
Look for the lot number 2024013122 on the Vivoo Protein Test strips.
The Vivoo Protein Test strips were distributed before being legally approved for U.S. customers, which could cause false or inaccurate results.
Check for the lot number 2024013122 on the Vivoo Protein Test strips, which were sold before January 30, 2026.
The recall does not require immediate stop use; check the lot number to confirm if your product is affected.
We’ve drafted a message you can send Vivoo to request your refund or repair — edit it as you like.
Subject: Recall Z-1265-2026 — Vivoo Vivoo Hello, I own a Vivoo that is covered by recall Z-1265-2026 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.
