Class 2 Device Recall ColoSense

• Date Initiated by Firm: May 20, 2025
• Date Posted: July 03, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2077-2025
• Recall Event ID: 97017
• PMA Number: P230001
• Product Classification: System, Colorectal Neoplasia, RNA Markers and Hemoglobin detection - Product Code SBB
• Product: ColoSense Test Kit, Part No. 80-001, component of ColoSense test
• Code Information: Lot number 80-001-A2501
• Recalling Firm/ Manufacturer: Geneoscopy, Inc.; 2220 Welsch Industrial Ct; Saint Louis MO 63146-4222
• For Additional Information Contact: Erica Barnell; 314-887-7777
• Manufacturer 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.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: 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.
• Quantity in Commerce: 10 units
• Distribution: US Nationwide distribution in the state of Missouri.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = SBB