Enterix, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0590-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.

Product Classification:

Class II

Date Initiated: October 8, 2020

Date Posted: December 23, 2020

Recall Number: Z-0590-2021

Event ID: 86674

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

Status: Terminated

Product Quantity: US: 5,256 vials (131,400 test strips); OUS:1051 vials

Code Information:

Lot Numbers: 770G11 and 770G21

Distribution Pattern:

Worldwide distribution - US Nationwide and the country of Australia.

Voluntary or Mandated:

Voluntary: Firm initiated