The Recall Desk
ModerateFDA (Devices)·Z-2077-2025·Announced 2025-07-09

ColoSense Test Kit Components Recalled for Control Failures

Geneoscopy, Inc. is recalling ColoSense Test Kit Part No. 80-001 (Lot 80-001-A2501) due to multiple plate failures caused by Low Positive Template Control being too high and out of range.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is a performance/quality defect (out-of-range control) that affects test reliability rather than direct patient harm, warranting a Moderate classification.

Plain-English summary

Geneoscopy, Inc. is recalling the ColoSense Test Kit, Part No. 80-001, component of the ColoSense test. The recall affects 10 units of lot number 80-001-A2501 that were distributed nationwide in the state of Missouri.

Multiple plate failures have been documented as a result of the Low Positive Template Control being too high and out of range in the affected lot. This out-of-range control condition compromises the reliability of test results.

Consumers and healthcare providers who have received this product should stop using the affected lot immediately and contact Geneoscopy, Inc. for a replacement or further instructions.

The recalled product

Product
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Manufacturer
Geneoscopy, Inc.
Category
Medical Device — Diagnostic Test Kit
Hazard
  • quality-defect
  • control-out-of-range

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot number 80-001-A2501

Distribution

Distributed nationwide across the United States.

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