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Open, Classified

ColoSense Test Kit, Part No. 80-001, component of ColoSense test

FDA Recall Z-2077-2025 · Posted 2025-07-03

Recalling FirmGeneoscopy, Inc.
Recall StatusOpen, Classified
Product CodeSBB
Date Initiated2025-05-20
Product Quantity10 units

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.

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.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

US Nationwide distribution in the state of Missouri.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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