FDA DevicesClass II
Male Fertility Sperm Test for Home Use (Cassette)
Published: February 11, 2026Recall ID: Z-1262-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Male Fertility Sperm Test for Home Use (Cassette)
Additional Source Details
| Field | Value |
|---|---|
| City | Changchun |
| State | N/A |
| Event id | 97801 |
| Address 1 | 2336, Tianwei Road |
| Address 2 | Beihu Science and Technology Development Zone |
| Code info | Name/Lot(Expiration): Male Fertility Sperm Test for Home Use (Cassette)/GT-SPA 20251601(05-2027) |
| Postal code | N/A |
| Report date | 20260211 |
| Product type | Devices |
| Product 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251122 |
| Initial firm notification | Letter |
| Center classification date | 20260204 |
Overview
- Recalling FirmChangchun Wancheng Bio-Electron Co., Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of TX, GA, CA.