Home › Fertility Solutions, Inc. › Fertility Solutions
Fertility Solutions
Fertility Solutions, Inc. · Model FSI103 · UDI-DI 08600105181066
3
510(k) clearances
0
Adverse events
1
Recalls
11
Facilities
Description
Sperm Count Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 levels - high and low concentrations. https://www.fertilitysolutions.com/product-category/sperm-count-quality-control
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-22 | Changchun Wancheng Bio-Electron Co., Ltd. | 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 fa |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.