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SIGHT DIAGNOSTICS LTD Recall: Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1

SIGHT DIAGNOSTICS LTD Recall: Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: SIGHT DIAGNOSTICS LTD; Product: Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1; Reason for recall: The default reference ranges for M

Recalling firmSIGHT DIAGNOSTICS LTD
ProductSight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Reason for recallThe 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionWorldwide 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 co
Recall initiated20220614
Recall numberZ-1469-2022
Categorydevice
CountryIsrael

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