Company: Sight Diagnostics LTD
Date of Enforcement Report: 7/27/2022
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
The default reference ranges for MCH, MCHC, and RDW for age group “Child 2-11y” are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 18.104.22.168. Due to the issue, results may incorrectly appear to be within or outside the reference range.
SIGHT DIAGNOSTICS LTD. Voluntary.
Worldwide distribution – US Nationwide distribution in the states of Alabama, Arizona, California, Florida, Idaho, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee,Texas, Virginia, Washington, Wisconsin and the countries of Burkina Faso, Belize, Canada, Cote D’Ivoire, Cameroon, Curacao, Germany, Spain, Finland, United Kingdom, Greece, more…