Saint Louis, MO, United States
Geneoscopy, Inc. recalls
1 recall recorded since 2018, most recently on 20 May 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 May 2025
- Reason
- 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.
- Distribution
- US Nationwide distribution in the state of Missouri.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2077-2025
- ColoSense Test Kit, Part No. 80-001, component of ColoSense test
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.