Geneoscopy recalls ColoSense Test Kit (Lot 80-001-A2501) due to plate failures from incorrect template control levels. Affected users should contact for remedy.
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.
Geneoscopy is recalling a specific ColoSense Test Kit component because it can fail due to a high positive template control level. This could lead to inaccurate test results if used without proper calibration.
The test kit component can fail when the positive template control level is too high, causing inaccurate results. This happens because the control level is outside the acceptable range during testing.
Users of the ColoSense Test Kit component (Lot 80-:001-A2501) who perform colon cancer screening tests. Those with medical conditions requiring precise test results may be at higher risk.
Check for the product name 'ColoSense Test Kit' with part number 80-001 and lot number 80-001-A2501. The recall applies to specific batches sold by Geneoscopy.
Verify the lot number on your ColoSense Test Kit component (80-001-A2501) to confirm if it's affected.
The recall is for potential inaccurate test results due to plate failures, not immediate safety risks. The hazard is low risk.
Check for the lot number 80-001-A2501 on the ColoSense Test Kit component (part number 80-001).
The recall does not specify a remedy, so contact Geneoscopy directly for guidance.
We’ve drafted a message you can send Geneoscopy to request your refund or repair — edit it as you like.
Subject: Recall Z-2077-2025 — Geneoscopy Geneoscopy Hello, I own a Geneoscopy that is covered by recall Z-2077-2025 from Geneoscopy. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
