Changchun Wancheng Bio-Electron Co., Ltd. recalls Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

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.

Exploro Highly Sensitive Male Fertility / Sperm Concentration Test

Starting on 11/22/2025, recall notices were mailed or emailed to customers/distributors who were asked to do the following: 1) Destroy unused devices. 2) Inform customers that test results may be inaccurate, and it is recommended to re-test. 3) If affected devices were further distributed, please forward this notice and response form to these additional customers or email us a customer distribution list with names, emails, addresses, phone numbers so we can notify your customers of the recall. 4) Complete and return the Acknowledgement and Receipt Form via email to: sales04@ccwancheng.com Questions can be emailed to the firm at: sales01@ccwancheng.com / sales04@ccwancheng.com

• FDA enforcement recordOfficial FDA database entry for Z-1263-2026
• FDA device classification · DFQOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.5800The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Changchun Wancheng Bio-Electron Co., Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.