Male Fertility Sperm Test for Home Use (Cassette)
- Recall Initiated
- November 22, 2025
- Posted
- February 4, 2026
- Recall Number
- Z-1262-2026
- Quantity
- 1,000
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of TX, GA, CA.
Lot / Code Info
Name/Lot(Expiration): Male Fertility Sperm Test for Home Use (Cassette)/GT-SPA 20251601(05-2027)
Root Cause
No Marketing Application
Action Taken
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