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ColoSense Collection Kit
Geneoscopy, Inc. · Model 0 · UDI-DI 00198715728941
SBB
Prescription
0
510(k) clearances
0
Adverse events
1
Recalls
3
Facilities
Description
Device is a stool collection kit for at-home use.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-20 | Geneoscopy, Inc. | Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit. |
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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.