BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979

    Recall: Z-2480-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2480-2020
    Event ID
    85762
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 8, 2020
    Initiation Date
    May 20, 2020
    Classification Date
    July 1, 2020
    Termination Date
    November 16, 2022
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979

    Reason

    Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances

    Code Info

    Affected Serial Number Range: J36000109-J36001317

    Distribution

    US Nationwide Distribution Foreign: Country AR AU BR CA CL CN CO DO FR ID IN JP KR MX MY NP PE PH SG TH TT VE VN

    Quantity

    779 (U.S.= 225;OUS= 554)