FDAJune 14, 2022device
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
sight diagnosticssight
Recall history
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