Z-2077-2025Class II

ColoSense Test Kit, Part No. 80-001, component of ColoSense test

Name: Z-2077-2025 ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Creator: Geneoscopy, Inc.
Published: 2025-05-20
License: https://open.fda.gov/license/

Geneoscopy, Inc. / initiated 2025-05-20 / Open, Classified

FDA source

Geneoscopy, Inc. began a recall of ColoSense Test Kit, Part No. 80-001, component of ColoSense test on 2025-05-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2077-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-20
Posted: 2025-07-03
Recalling firm: Geneoscopy, Inc.
Product: ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Product code: SBB System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
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.
FDA 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 in commerce: 10 units
Distribution: US Nationwide distribution in the state of Missouri.
Product codes and lots: Lot number 80-001-A2501

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2077-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2077-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-09	2025-07-03

Product code SBB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)