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

ColoSense Test Kit Recall: Quality Control Failure

Geneoscopy is recalling ColoSense Test Kit, Part No. 80-001, lot 80-001-A2501, because the Low Positive Template Control was out of range, causing multiple plate failures.

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 recall with no reported illnesses or injuries. The issue is a manufacturing quality control problem affecting a limited number of units. No patient harm has been documented.

Plain-English summary

Geneoscopy, Inc. is recalling the ColoSense Test Kit, Part No. 80-001, a component of the ColoSense test system, lot 80-001-A2501.

The recall is due to a manufacturing quality control issue in which the Low Positive Template Control was too high and out of range. Multiple plate failures have been documented in the affected lot as a result of this out-of-range control.

The recalled lot comprised 10 units. Customers who have received test kits from lot 80-001-A2501 should contact Geneoscopy, Inc. for instructions regarding replacement or return of the affected kits.

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
  • device-malfunction

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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