Device product
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Z-2077-2025
Product summary
- Firm
- Geneoscopy, Inc.
- Event
- Event 97017
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-2077-2025
Official wording
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.
Code information: Lot number 80-001-A2501
Distribution pattern: US Nationwide distribution in the state of Missouri.
Derived failure modes
-
Unknown
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.