BEUDAMED
    FDA Enforcement Class II Terminated

    cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use

    Recall: Z-0752-2021 · Reported January 6, 2021

    Enforcement

    Recall Number
    Z-0752-2021
    Event ID
    86897
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 6, 2021
    Initiation Date
    November 23, 2020
    Classification Date
    December 29, 2020
    Termination Date
    July 6, 2023
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use

    Reason

    During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).

    Code Info

    Catalog Number 08445605190 08445567190 08253153190 08058580190

    Distribution

    Domestic: IL, FL, GA, WV

    Quantity

    152 kits and 7 units