Changchun Wanch: LH One Step Ovulation Test Device (GT-LH 20251601) may give false results, leading to incorrect medical decisions. Affected units sold before legal U.S. 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 is recalling LH One Step Ov: Urine ovulation test devices that could give false results. This might lead to unnecessary medical treatments if users rely on the test for pregnancy planning.
The test devices were distributed before receiving U.S. regulatory approval. This means they might not work correctly, causing false positive or negative results. If users act on inaccurate results, they could get unnecessary medical care.
Women using LH One Step Ovulation Test devices for pregnancy planning are affected. Those who have the specific lot number GT-LH 20251601 (expiring May 2027) are most at risk.
Check for the lot number GT-LH 20251601 on the device packaging. The product was sold with an expiration date of May 2027.
Look for the lot number GT-LH 20251601 on the packaging or device label.
The device expires May 2027; if it's past this date, it should not be used.
The devices were distributed before receiving U.S. regulatory approval, which may cause false results and lead to inappropriate medical interventions.
Check the lot number on the packaging. If it's GT-LH 20251601, it's affected and may give false results.
The official recall does not mention a fix; affected units should be checked for the lot number and discarded if necessary.
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-1259-2026 — Changchun Wancheng Bio-Electron Changchun Wancheng Bio-Electron Hello, I own a Changchun Wancheng Bio-Electron that is covered by recall Z-1259-2026 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.
