Reported Jul 9, 2025 · Ongoing
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Geneoscopy, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Geneoscopy, Inc. · 2220 Welsch Industrial Ct · Saint Louis, MO · 63146-4222
Is this the product you have?
- ColoSense Test Kit, Part No. 80-001, component of ColoSense test
- Lot codes and dates
- Lot number 80-001-A2501
- Amount recalled
- 10 units
Where it was sold
- Nationwide
- MO
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.
This product could cause temporary or reversible health problems — stop using it.
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