Class II — Enterix, Inc.
| Recalling firm | Enterix Inc |
|---|---|
| Registered facility | ENTERIX PTY LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy or sigmoidoscopy |
| Product | InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01. |
| Quantity | US: 5,256 vials (131,400 test strips); OUS:1051 vials |
| Distribution | Worldwide distribution - US Nationwide and the country of Australia. |
| Initiated | 2020-10-08 |
| Classified | 2020-12-15 |
| Terminated | 2023-01-10 |
| Recall number | Z-0590-2021 |
| 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-0590-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86674/
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