FDA-Device2026-02-11Class IIMISBRANDING

Changchun Wancheng Male Fertility Sperm Test recalled for inaccurate results

FALSE CLAIMSNationwide distributiondevice

Stop using Changchun Wancheng sperm test kit

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

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.

Who it affects

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-1262-2026

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