Z-2077-2025 Class II Ongoing
FDA device recall Z-2077-2025 was initiated by Geneoscopy, Inc. on May 20, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 9, 2025
- Initiation Date
- May 20, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
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.
Distribution Pattern
US Nationwide distribution in the state of Missouri.
Code Information
Lot number 80-001-A2501