Recall Weekly
Moderate riskFDA DeviceClass II

Changchun Wancheng sperm test recalled for possible inaccurate results

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.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using the Male Fertility Sperm Test for Home Use (Cassette), lot GT-SPA 20251601 with expiration 05-2027
  2. Discard the test kit
  3. If you used this test and made medical decisions based on the results, contact your doctor to discuss next steps
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Male Fertility Sperm Test for Home Use (Cassette)
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

This recall covers 11 products — see all of them.

Details

Units affected
1,000
Illnesses reported
None reported
Manufactured in
2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, China
Classification
Class II
Recall number
Z-1262-2026

In the FDA's words

Description
Male Fertility Sperm Test for Home Use (Cassette) 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. Name/Lot(Expiration): Male Fertility Sperm Test for Home Use (Cassette)/GT-SPA 20251601(05-2027) Distribution: US Nationwide distribution in the states of TX, GA, CA. Affected quantity: 1,000
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.

11 products in this recall

LotFancy, Vivoo and URIMED urine test strips recalled over unauthorized marketing

Changchun Wancheng is recalling 11 product listings of home test strips and diagnostic tests, including urinary tract infection, ovulation, menopause, fertility and Vivoo tests. The devices were distributed in the U.S. before FDA clearance (510(k)), and they may give false or inaccurate results to users, which could lead to inappropriate medical treatment. The recall was distributed nationwide, with confirmed distribution in Texas, Georgia and California.

The agency lists each product separately. Check every one you might have.

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