FDA-Device2013-08-28Class II
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
Beckman Coulter Inc.
Hazard
Beckman Coulter has received a customer complaint that suggests trending of positive results has increased from approximately 4% to 1 0%. As a result of our investigation, Beckman Coulter has confirmed an increase in sensitivity at the borderline positive level. " This testing also demonstrated that the issue does not affect results reported as negative.
Sold states
Worldwide Distribution - USA and the country of Canada.
Affected count
68,116 units
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1997-2013Don't want to check this manually?
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