Enterix, Inc. recalls InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit

Recalling company

Enterix, Inc.

Product

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.

Reason

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

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Sep 17, 2025

Reported

Dec 10, 2025

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.

Status

Ongoing

Quantity

201,426 test kits

Lot / codes

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.

Company location

Edison, NJ

Recall type

Voluntary: Firm initiated

Recall number

Z-0725-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0725-2026 in the FDA Enforcement Report. Also see FDA recall press releases.