InSure ONE Test Strips — Class II medical device recall Z-0590-2021
Terminated recall by Enterix, Inc., reported 2020-12-23, distributed nationwide. Product does not meet internal testing criterion; use of the product may result in a potential false positive
| Recall number | Z-0590-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Enterix, Inc., Edison, NJ, United States |
| Recall initiated | 2020-10-08 |
| Classified | 2020-12-15 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2023-01-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Lot numbers | 770G11, 770G21 |
| Model numbers | 12045.01 |
Product
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0590-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.