Z-0725-2026 Class II Ongoing
FDA device recall Z-0725-2026 was initiated by Enterix, Inc. on September 17, 2025 and is designated Class II. Reason for recall: InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. The recall status is ongoing. Affected quantity: 201,426 test kits.
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.