United StatesInSure ONE Fecal Immunochemical Test labeled as InSure ONE POL Patient Kit — 10 pack (model 90010, GTIN 10850093003313), 25 pack (model 90025, GTIN 20850093003310), and POL Combo Pack (model 90030, GTIN 00850093003279), all lots produced 7/23/2025–9/12/2025 with Test card lot TT241102, are affected. The kits were recalled because InSure ONE failed sensitivity testing when used with Test Card Lot TT241102, which may result in false negative results; they were distributed worldwide, including multiple U.S. states and the Philippines.
What's being recalled
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.
Recalling firm: Enterix, Inc., Edison, NJ, United States.
How to identify it
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.
The hazard
InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)