Geneoscopy, Inc. recalls ColoSense Test Kit

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.

On May 20, 2025, the firm initiated a voluntary removal of the affected test kit lot. An internal recall notification was sent to the affected CLIA Laboratory Director. All remaining test kits were removed from the CLIA laboratory. The firm's investigation of the root cause for this issue is ongoing.

• FDA enforcement recordOfficial FDA database entry for Z-2077-2025
• FDA device classification · SBBOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Geneoscopy, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.