BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.

    Recall: Z-1348-2016 · Reported April 13, 2016

    Enforcement

    Recall Number
    Z-1348-2016
    Event ID
    73429
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2016
    Initiation Date
    February 16, 2016
    Classification Date
    April 7, 2016
    Termination Date
    May 30, 2018
    Address
    100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States

    Description

    VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.

    Reason

    The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.

    Code Info

    Product Codes: 6802413, 6802915 (Refurbished) Serial numbers: J56000024 - J56002387

    Distribution

    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.

    Quantity

    2,101 Total units (1,043 domestically & 1,058 internationally)