Class II — Geneoscopy, Inc.
| Recalling firm | Geneoscopy Inc |
|---|---|
| Registered facility | GENEOSCOPY INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | ColoSense Test Kit, Part No. 80-001, component of ColoSense test |
| Quantity | 10 units |
| Distribution | US Nationwide distribution in the state of Missouri. |
| Initiated | 2025-05-20 |
| Classified | 2025-07-03 |
| Recall number | Z-2077-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Geneoscopy, Inc. (Z-2077-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97017/
Alerts for Geneoscopy Inc
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.