Geneoscopy, Inc.: Device Recall
Recall #Z-2077-2025 · 05/20/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2077-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Geneoscopy, Inc.
- Status
- Ongoing
- Date Initiated
- 05/20/2025
- Location
- Saint Louis, MO, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 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.
Product Description
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Distribution Pattern
US Nationwide distribution in the state of Missouri.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.