BEUDAMED
    FDA Enforcement Class II Terminated

    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

    Recall: Z-2517-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2517-2021
    Event ID
    88401
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SIGHT DIAGNOSTICS LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 29, 2021
    Initiation Date
    March 17, 2021
    Classification Date
    September 22, 2021
    Termination Date
    June 8, 2022
    Address
    23, Derekh Menakhem Begin, Tel Aviv-Yafo, N/A, Israel

    Description

    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

    Reason

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

    Code Info

    Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10

    Distribution

    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.

    Quantity

    114 units