Changchun Wancheng Bio-Electron recalls Menopause Test Cassette (Urine) GT-FSH 20251601 (05-2027) due to potential false results causing unnecessary medical interventions.
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 Menopause Test Cassette (Urine) GT-FSH 20251601 (05-2027) because the test may give false results, leading to incorrect medical decisions. This could cause unnecessary treatments or delays in proper care.
The test strips were distributed before meeting U.S. regulatory requirements, which can cause false or inaccurate results when used by individuals. This may lead to inappropriate medical interventions if the results are misinterpreted.
Women using the Menopause Test Cassette (Urine) GT-FSH 20251601 (05-2027) for home testing are affected. Those who rely on the test for medical decisions face the highest risk of inaccurate results.
Check for the product name 'Menopause Test Cassette (Urine)' and lot number GT-FSH 20251601 with expiration date 05-2027. The product was sold in the U.S. before regulatory approval.
Identify the lot number GT-FSH 20251601 and expiration date 05-2027 on the test cassette packaging.
The recall states the test may cause false results, so it is not recommended for accurate medical decisions.
The official recall does not specify a remedy, so contact the manufacturer for guidance.
Look for the lot number GT-FSH 20251601 and expiration date 05-2027 on the test cassette packaging.
We’ve drafted a message you can send Changchun Wanch: Bio-Electron to request your refund or repair — edit it as you like.
Subject: Recall Z-1260-2026 — Changchun Wanch: Bio-Electron Changchun Wanch: Bio-Electron Hello, I own a Changchun Wanch: Bio-Electron that is covered by recall Z-1260-2026 from Changchun Wanch: 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.
