27
Jul
2022

Recall- Software Error May Lead to Age Outside Reference Range

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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…

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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