Recall Z-2077-2025— Geneoscopy, Inc.

Name: FDA recall Z-2077-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-20

Class II · Ongoing

Class II FDA medical device recall by Geneoscopy, Inc., initiated 2025-05-20. FDA's recall record names no specific 510(k) clearance for this event. Product: ColoSense Test Kit, Part No. 80-001, component of ColoSense test. Reason: 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.
Classification: Class II
Status: Ongoing
Initiated: 2025-05-20
Firm location: Saint Louis, MO, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.