FDA Medical Device Recalls (openFDA)
Geneoscopy, Inc.: ColoSense Test Kit, Part No. 80-001, component of ColoSense test
- Recall number
- Z-2077-2025
- Recalling firm
- Geneoscopy, Inc.
- Product
- ColoSense Test Kit, Part No. 80-001, component of ColoSense test
- Status
- Open, Classified
- Initiated
- 2025-05-20
- Posted
- 2025-07-03
- Terminated
- not on file
- 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.
- Root cause
- Unknown/Undetermined by firm
- Action
- On May 20, 2025, the firm initiated a voluntary removal of the affected test kit lot. An internal recall notification was sent to the affected CLIA Laboratory Director. All remaining test kits were removed from the CLIA laboratory. The firm's investigation of the root cause for this issue is ongoing.
- Quantity
- 10 units
- Distribution
- US Nationwide distribution in the state of Missouri.
- Lot, serial or model codes
- Lot number 80-001-A2501
- 510(k) numbers
- not on file
- PMA numbers
- ["P230001"]
- Product code
- SBB
- Firm FEI
- 3026996410
- Firm city
- Saint Louis
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28