FDA recall Z-2077-2025

Geneoscopy, Inc. · Class II · device

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

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

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