FDA-Device2026-02-11Class IIMISBRANDING
Changchun Wancheng Male Fertility Sperm Test recalled for inaccurate results
What this means
Changchun Wancheng Bio-Electron Co., Ltd. distributed a home sperm fertility test kit without proper FDA approval. The test may give false or inaccurate results, which could lead to unnecessary or inappropriate medical decisions based on incorrect information.
- Stop using the Male Fertility Sperm Test for Home Use (Cassette), lot GT-SPA 20251601 with expiration 05-2027
- Discard the test kit
- If you used this test and made medical decisions based on the results, contact your doctor to discuss next steps
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of TX, GA, CA.
Affected count
1,000
Manufactured in
2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, China
Products
Male Fertility Sperm Test for Home Use (Cassette)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1262-2026Want us to check the next one for you?
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