Company: Sight Diagnostics LTD
Date of Enforcement Report: 7/27/2022
Class II
PRODUCT
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Recall Number:
Z-1469-2022
REASON
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.
RECALLING FIRM/MANUFACTURER
SIGHT DIAGNOSTICS LTD. Voluntary.
DISTRIBUTION
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…
