[pending] Male Fertility Sperm Test for Home Use (Cassette)
Pending LLM rewrite. Source: FDA_DEVICE Z-1262-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Male Fertility Sperm Test for Home Use (Cassette)
- Manufacturer
- Changchun Wancheng Bio-Electron Co., Ltd.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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