Enterix InSure ONE Fecal Test May Give False Negatives with Specific Test Cards
Enterix recalls InSure ONE fecal immunochemical test kits that may produce false negative results when used with Test Card Lot T241102. Affected kits include 10-pack and 25-pack models produced between July 23 and September 12, 2025.
Lower-risk recall
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
Contact the company
What happened, in plain English
Enterix is recalling InSure ONE fecal immunochemical test kits that may give false negative results when used with specific test cards. This could lead to missing early signs of colorectal cancer in users who rely on these tests for screening. Read more at govinfonow.com/recall/51279-enterix-insure-one-fecal-test-may-give-false-negatives-with.
Source Summary by GovInfoNow · govinfonow.com/recall/51279-enterix-insure-one-fecal-test-may-give-false-negatives-with · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0725-2026
Cite this page
“Enterix InSure ONE Fecal Test May Give False Negatives with Specific Test Cards.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51279-enterix-insure-one-fecal-test-may-give-false-negatives-with. Based on FDA recall #Z-0725-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0725-2026%22&limit=1).
Why it’s dangerous
The test may produce false negative results when used with Test Card Lot T241102, meaning it could miss early signs of colorectal cancer. This happens because the test's sensitivity fails under specific conditions with this test card lot.
Who’s affected
People who purchased the InSure ONE fecal test kits (10-pack or 25-pack models) with Test Card Lot T241102 between July 23 and September 12, 2025. Those who use these tests for colorectal cancer screening are most at risk.
How to tell if you have this one
Check the model number on the kit: 90010 (10-pack), 90025 (25-pack), or 90030 (combo pack). Look for Test Card Lot T241102 on the test card. The kits were produced between July 23 and September 12, 2025.
- Brand
Enterix- Product
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010- Category
Medical device
What to do — step by step
Check Kit Model Number
Look for model numbers 90010, 90025, or 90030 on the kit packaging.
Verify Test Card Lot
Check the test card for lot number T241102 to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 16 states.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Nevada, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Texas, Washington, West Virginia.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these tests?
No, the recall does not require stopping use. The tests may give false negatives but are still safe to use with other test card lots.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0725-2026 (September 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0725-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.