Changchun Wancheng Bio-Electron Recalls Male Fertility Sperm Tests Due to Lack of FDA Clearance

What Happened

Changchun Wancheng Bio-Electron Co., Ltd. has initiated a voluntary recall of its Male Fertility Sperm Test for Home Use (Cassette). The recall was prompted because the test strips and diagnostic components were distributed to U.S. customers before they could be legally marketed through the required 510(k) clearance process. According to the FDA, these unapproved devices may produce false or inaccurate diagnostic results, which could lead consumers to pursue inappropriate medical interventions.

Which Products Are Affected

The recall involves approximately 1,000 units of the following product:

• Product Name: Male Fertility Sperm Test for Home Use (Cassette)
• Lot Number: GT-SPA 20251601
• Expiration Date: 05-2027
• Recall Number: Z-1262-2026

The affected products were distributed nationwide within the United States, with confirmed distribution in Texas, Georgia, and California.

What You Should Do

Consumers who have purchased the affected test kits should stop using them immediately. The recalling firm, Changchun Wancheng Bio-Electron Co., Ltd., initiated the notification process via letter. Consumers seeking information regarding returns or refunds should contact the firm at their headquarters at 2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, China.

Why This Matters

The use of diagnostic tests that have not been cleared by the FDA poses a risk of inaccurate health data. Inaccurate results from a fertility test could lead to incorrect self-diagnosis and unnecessary or harmful medical decisions.

Source

Information provided by the FDA.