[pending] ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Pending LLM rewrite. Source: FDA_DEVICE Z-2077-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- ColoSense Test Kit, Part No. 80-001, component of ColoSense test
- Manufacturer
- Geneoscopy, Inc.
- Category
- Medical Device — Devices
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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