# FDA recall Z-2077-2025

> **Geneoscopy, Inc.** · Class II · device recall initiated 2025-05-20.

## Product

ColoSense Test Kit, Part No. 80-001, component of ColoSense test

## Reason for recall

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.

## Distribution

US Nationwide distribution in the state of Missouri.

## Key facts

- **Recall number:** Z-2077-2025
- **Recalling firm:** Geneoscopy, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-20
- **Report date:** 2025-07-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Louis, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2077-2025

## Citation

> AI Analytics. FDA recall Z-2077-2025. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-2077-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*