Male Fertility Sperm Test for Home Use (Cassette)
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | November 22, 2025 |
| Reported | February 11, 2026 |
| Recalling firm | Changchun Wancheng Bio-Electron Co., Ltd. |
| Country / region | China N/A |
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.
Affected products
- Male Fertility Sperm Test for Home Use (Cassette)
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