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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Affected units
- 10
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
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