FDA-Device2020-12-23Class II
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
Enterix, Inc.
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
Sold states
Worldwide distribution - US Nationwide and the country of Australia.
Affected count
US: 5,256 vials (131,400 test strips); OUS:1051 vials
Manufactured in
236 Fernwood Ave, N/A, Edison, NJ, United States
Products
InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0590-2021Don't want to check this manually?
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