BEUDAMED
    FDA Enforcement Class II Terminated

    cobas c513 Analyzer

    Recall: Z-2478-2019 · Reported September 11, 2019

    Enforcement

    Recall Number
    Z-2478-2019
    Event ID
    83525
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2019
    Initiation Date
    July 18, 2019
    Classification Date
    September 5, 2019
    Termination Date
    June 15, 2020
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    cobas c513 Analyzer

    Reason

    Quality issue with high pressure solenoid valves

    Code Info

    Serial # :1731-08, 1722-03

    Distribution

    State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK

    Quantity

    2 units