Class II — Enterix, Inc.
| Recalling firm | Enterix Inc |
|---|---|
| Registered facility | ENTERIX PTY LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. |
| 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. |
| Quantity | 201,426 test kits |
| 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. |
| Initiated | 2025-09-17 |
| Classified | 2025-11-28 |
| Recall number | Z-0725-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Enterix, Inc. (Z-0725-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97802/
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