Enterix, Inc.: 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.

Hazard

InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.

Details from the source

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. Quantity: 201,426 test kits 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.

UPC codes

10850093003313, 20850093003310, 00850093003279

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.