InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 9001
Summary
The FDA issued a Class II for InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL P by Enterix, Inc.. Reason: InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results..
Details
Source
Device Recall
External ID
Z-0725-2026
Action Date
2025-12-10
Status
Ongoing
Category
device
Product Description
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples.
Lot/Code Info: 1. Model Number: 90010; GTIN:10850093003313; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 2. Model Number: 90025; GTIN: 20850093003310; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102. 3. Model Number: 90030; GTIN: 00850093003279; All lots produced from 7/23/2025-9/12/2025 with Test card lot TT241102.
Quantity Affected: 201,426 test kits
Reason for Recall
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Distribution
Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Washington, West Virginia and the country of Philippines.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-17
Company
Edison, NJ
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 336 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 (Enterix, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Enterix, Inc. have FDA actions?
This is the only FDA action we have on record for Enterix, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0725-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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