FDAMarch 17, 2021device
Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
What to do
FDA enforcement status: Terminated
Brands named
sight diagnosticssight
Recall history
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