Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ColoSense Test Kit Recalled by Geneoscopy, Inc. Due to Multiple plate failures documented as a result of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Geneoscopy, Inc. directly.
Affected Products
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Quantity: 10 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Geneoscopy, Inc.
Geneoscopy, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report