# FDA recall Z-0590-2021

> **Enterix, Inc.** · Class II · device recall initiated 2020-10-08.

## 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

## Distribution

Worldwide distribution - US Nationwide and the country of  Australia.

## Key facts

- **Recall number:** Z-0590-2021
- **Recalling firm:** Enterix, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-08
- **Report date:** 2020-12-23
- **Termination date:** 2023-01-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Edison, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0590-2021

## Citation

> AI Analytics. FDA recall Z-0590-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0590-2021. Source: US FDA. Licensed CC0.

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