Class II

Medical Device Recall: ColoSense Test Kit, Part No. 80-001, component of ColoSense test

Geneoscopy, Inc. · May 20, 2025

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.

States Affected

NATIONWIDE

Quantity Affected

10 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2077-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Geneoscopy, Inc. Medical Device Recall: ColoSense Test Kit, Part No. 80-001, component of ColoSense test | SafeCheck