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Geneoscopy, Inc. recalls ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Recalled July 9, 2025 · FDA recall Z-2077-2025 · Geneoscopy
Hazard
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. · FDA Class II
Units
10 units
Sold at
US Nationwide distribution in the state of Missouri.
Description
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
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Manufacturer(s)
Geneoscopy, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →