Geneoscopy, Inc. recalls ColoSense Test Kit, Part No. 80-001, component of ColoSense test
- Recall date
- May 20, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2077-2025
- FDA classification
- Class II
- Brand / firm
- Geneoscopy, Inc.
- Sold / distributed
- US Nationwide distribution in the state of Missouri.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
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