ColoSense Test Kit (Geneoscopy) – Plate Control Error (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Brand
Geneoscopy, Inc.
Lot Codes / Batch Numbers
Lot number 80-001-A2501
Products Sold
Lot number 80-001-A2501
Geneoscopy, Inc. is recalling ColoSense Test Kit, Part No. 80-001, component of ColoSense test due to 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 ColoSens. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026