Home / Recalls / Enterix, Inc. / Z-0725-2026

Z-0725-2026 Class II Ongoing

Recalled by Enterix, Inc. — Edison, NJ

Recall Details

Product Type: Devices
Report Date: December 10, 2025
Initiation Date: September 17, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 201,426 test kits

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.

Reason for Recall

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

Distribution Pattern

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.

Code Information

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.