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Sapyen At-Home Male Fertility Analysis Kit
VITO HEALTH PTY LTD · Model 1 · UDI-DI 09309000599004
10
510(k) clearances
287
Adverse events
17
Recalls
113
Facilities
Description
Sapyen At-Home Male Fertility Analysis Kit - At-home male fertility diagnostic kit, which enables customers to collect semen samples from the comfort of their own home without having to rush out the door to drop their sample to the nearest testing centre. Our kit extends the shelf life of sperm, so customers can send their sample via normal postal services to accredited labs for semen analysis. After the analysis, customers receive a comprehensive report explaining the results on each of their parameters and providing recommendations that consider their health history.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-01-09 | Heritage Labs International LLC | Kits contain recalled Triad alcohol pads |
| 2011-01-09 | Heritage Labs International LLC | Kits contain recalled Triad alcohol pads |
| 2011-01-09 | Heritage Labs International LLC | Kits contain recalled Triad alcohol pads |
| 2011-01-09 | Heritage Labs International LLC | Kits contain recalled Triad alcohol pads |
| 2011-01-09 | Heritage Labs International LLC | Kits contain recalled Triad alcohol pads |
| 2011-01-09 | Heritage Labs International LLC | Kits contain recalled Triad alcohol pads |
| 2011-01-09 | Heritage Labs International LLC | Kits contain recalled Triad alcohol pads |
| 2011-01-09 | Heritage Labs International LLC | Kits contain recalled Triad alcohol pads |
| 2011-01-09 | Heritage Labs International LLC | Kits contain recalled Triad alcohol pads |
| 2011-01-09 | Heritage Labs International LLC | Kits contain recalled Triad alcohol pads |
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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.