FDA Device recall Z-2077-2025
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
- FDA Device
- Class II
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class II recall of ColoSense Test Kit, Part No. 80-001, component of ColoSense test by Geneoscopy, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2077-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-20 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Geneoscopy |
| Distribution | US |
Product
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
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.
Identifiers
| code_info | Lot number 80-001-A2501 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2077-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.