ColoSense Test Kit, Part No. 80-001, component of ColoSense test
FDA Recall #Z-2077-2025 — Class II — May 20, 2025
Product Description
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.
Recalling Firm
Geneoscopy, Inc. — Saint Louis, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10 units
Distribution
US Nationwide distribution in the state of Missouri.
Code Information
Lot number 80-001-A2501
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated