Home / Recalls / Enterix, Inc. / Z-0590-2021

Z-0590-2021 Class II Terminated

Recalled by Enterix, Inc. — Edison, NJ

Recall Details

Product Type: Devices
Report Date: December 23, 2020
Initiation Date: October 8, 2020
Termination Date: January 10, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: US: 5,256 vials (131,400 test strips); OUS:1051 vials

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.

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 Pattern

Worldwide distribution - US Nationwide and the country of Australia.

Code Information

Lot Numbers: 770G11 and 770G21