ColoSense Test Kit, Part No. 80-001, component of ColoSense test
This recall is currently active, issued July 3, 2025. It was issued by Geneoscopy, Inc..
- Company
- Geneoscopy, Inc.
- Recall Initiated
- May 20, 2025
- Posted
- July 3, 2025
- Recall Number
- Z-2077-2025
- Quantity
- 10 units
- Firm Location
- Saint Louis, MO
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot number 80-001-A2501
Root Cause
Unknown/Undetermined by firm
Action Taken
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.