Changchun Wanch: Male Fertility Sperm Test cassettes distributed before legal U.S. marketing may cause false results, leading to incorrect medical decisions. Affected units: GT-SPA 20251601 (expiring 05/2027).
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's home fertility test cassettes were recalled because they were distributed before being legally approved for U.S. use. This could cause false results, potentially leading to unnecessary medical treatments.
These test cassettes were distributed before receiving U.S. regulatory approval. As a result, they may produce false or inaccurate results when used by non-medical professionals, which could lead to inappropriate medical interventions.
Home users of the male fertility sperm test cassettes with lot number GT-SPA 20251601 (expiring 05/2027) are affected. Men who use these tests for self-diagnosis are most at risk of receiving inaccurate results.
Check for the lot number GT-SPA 20251601 on the cassette packaging. The product expires by May 2027. This specific model was distributed before legal U.S. marketing.
Look for the lot number GT-SPA 20251601 on the cassette packaging to confirm if it's affected.
The test cassettes were distributed before receiving U.S. regulatory approval, which may cause false or inaccurate results.
Using these cassettes could lead to incorrect medical decisions due to false results, but the risk is not life-threatening.
Check for the lot number GT-SPA 20251601 on the cassette packaging; this model expires by May 2027.
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-1262-2026 — Changchun Wancheng Bio-Electron Changchun Wancheng Bio-Electron Hello, I own a Changchun Wancheng Bio-Electron that is covered by recall Z-1262-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
