Changchun Wancheng Bio-Electron recalls UTI test strips that may give false results, leading to incorrect medical treatment. Affected products include various urine test strips with specific lot numbers.
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 is recalling UTI test strips that could produce false results, potentially causing unnecessary medical treatments. This recall affects specific lots of urine test strips sold under different brand names.
These test strips were distributed before receiving U.S. regulatory approval, which means they might not work correctly. False results could lead to inappropriate medical treatments if users rely on them for diagnosis.
People who purchased UTI test strips from Changchun Wancheng Bio-Electron or similar brands. Those using these strips for home urine testing are most at risk of receiving incorrect results.
Check the product name and lot number on the test strips. Affected products include brands like LotFancy, PALINOIA UTI-10, Vaunn Medical, JNW Direct, and Urinify with specific lot numbers listed in the recall notice.
Look for the product name and lot number on the test strips to determine if they are affected.
These test strips were distributed before they could be legally marketed to U.S. customers, which may cause false or inaccurate results.
Check the product name and lot number to see if they are affected; if so, stop using them and contact the manufacturer for further instructions.
Yes, the recall includes specific lot numbers listed in the product details, such as LotFancy/2025062001(06/19/2027) and others.
We’ve drafted a message you can send Changchun Wancheng Bio-Electron to request your refund or repair — edit it as you like.
Subject: Recall Z-1257-2026 — Changchun Wancheng Bio-Electron Changchun Wancheng Bio-Electron Hello, I own a Changchun Wancheng Bio-Electron that is covered by recall Z-1257-2026 from Changchun Wancheng Bio-Electron. 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.
