FDA Enforcement
Class II
Ongoing
Male Fertility Sperm Test for Home Use (Cassette)
Recall: Z-1262-2026
·
Reported February 11, 2026
Enforcement
- Recall Number
- Z-1262-2026
- Event ID
- 97801
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Changchun Wancheng Bio-Electron Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 11, 2026
- Initiation Date
- November 22, 2025
- Classification Date
- February 4, 2026
- Address
- 2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, N/A, N/A, China
Description
Male Fertility Sperm Test for Home Use (Cassette)
Reason
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.
Code Info
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.
Quantity
1,000