FDA Medical devices recall ·
ColoSense Test Kit, Part No recall
- Recall number
- Z-2077-2025
- Date
- (initiated May 20, 2025)
- Company / brand
- Geneoscopy, Inc.
2220 Welsch Industrial Ct, Saint Louis, MO, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 10 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot number 80-001-A2501
Distribution
US Nationwide distribution in the state of Missouri.
States: Missouri
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2077-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.