BEUDAMED
    FDA Enforcement Class II Terminated

    cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in diagnostic laboratories.

    Recall: Z-0107-2017 · Reported November 2, 2016

    Enforcement

    Recall Number
    Z-0107-2017
    Event ID
    75186
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 2, 2016
    Initiation Date
    July 15, 2016
    Classification Date
    October 25, 2016
    Termination Date
    June 5, 2017
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025, United States

    Description

    cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in diagnostic laboratories.

    Reason

    Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.

    Code Info

    Not applicable

    Distribution

    US Nationwide Distribution

    Quantity

    9014 in total