ColoSense Test Kit — Class II medical device recall Z-2077-2025
Ongoing recall by Geneoscopy, Inc., reported 2025-07-09, distributed nationwide. Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of
| Recall number | Z-2077-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Geneoscopy, Inc., Saint Louis, MO, United States |
| Recall initiated | 2025-05-20 |
| Classified | 2025-07-03 |
| Reported by FDA | 2025-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 10 units |
| Lot numbers | 80-001-A2501 |
| Model numbers | 80-001 |
Product
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2077-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.