Summary
The FDA issued a Class II for ColoSense Test Kit, Part No. 80-001, component of ColoSense test by Geneoscopy, Inc.. 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 ColoSens.
Details
Source
Device Recall
External ID
Z-2077-2025
Action Date
2025-07-09
Status
Ongoing
Category
device
Product Description
ColoSense Test Kit, Part No. 80-001, component of ColoSense test
Lot/Code Info: Lot number 80-001-A2501
Quantity Affected: 10 units
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.
Distribution
US Nationwide distribution in the state of Missouri.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-20
Company
Saint Louis, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 153 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Geneoscopy, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Geneoscopy, Inc. have FDA actions?
This is the only FDA action we have on record for Geneoscopy, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2077-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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