SIGHT DIAGNOSTICS LTD recalls Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.

Recalled September 29, 2021 · FDA recall Z-2517-2021 · SIGHT DIAGNOSTICS

Hazard

Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software · FDA Class II

Units

114 units

Sold at

Worldwide distribution - US Nationwide distribution in the states of Alabama, Florida, Massachusetts, Minnesota, Missouri, New York, Ohio, Texas, Virginia, Washington and the countries of AUSTRALIA, CHILE, UNITED KINGDOM, GEORGIA, ISRAEL, Mexico, NETHERLANDS, Portugal, Russia, Singapore, Thailand.

Description

Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software

Product

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

Manufacturer(s)

SIGHT DIAGNOSTICS LTD

Made in

Israel

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →