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Enterix, Inc. recalls InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from bloo
Recalled December 23, 2020 · FDA recall Z-0590-2021 · Enterix
Hazard
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 · FDA Class II
Units
US: 5,256 vials (131,400 test strips); OUS:1051 vials
Sold at
Worldwide distribution - US Nationwide and the country of Australia.
Description
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.
Manufacturer(s)
Enterix, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →