FDA recall Z-1469-2022

SIGHT DIAGNOSTICS LTD · Class II · device

Product

Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1

Reason for recall

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.

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, Hong Kong, Indonesia, Ireland, Israel, India, Italy, Mexico, Portugal, Qatar, Sweden, Slovenia, Chad, Thailand, South Africa.

Key facts

Status
Ongoing
Initiation date
2022-06-14
Report date
2022-08-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tel Aviv-Yafo, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1469-2022