FDA-Device2022-08-03Class II
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
SIGHT DIAGNOSTICS LTD
Hazard
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 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outside the reference range.
Sold states
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, Hong Kong, Indonesia, Ireland, Israel, India, Italy, Mexico, Portugal, Qatar, Sweden, Slovenia, Chad, Thailand, South Africa.
Affected count
72 US; 292 OUS
Manufactured in
23, Derekh Menakhem Begin, Tel Aviv-Yafo, Israel
Products
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1469-2022Don't want to check this manually?
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