BEUDAMED
    FDA Enforcement Class II Terminated

    cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.

    Recall: Z-1233-2016 · Reported March 30, 2016

    Enforcement

    Recall Number
    Z-1233-2016
    Event ID
    73292
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 30, 2016
    Initiation Date
    February 23, 2016
    Classification Date
    March 23, 2016
    Termination Date
    January 11, 2018
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.

    Reason

    Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport (RTT) after the decapping process. Therefore, open sample tubes can be dropped in the cobas p 512, spilling the sample material.

    Code Info

    Part numbers:05083435001 and 06268854001

    Distribution

    US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA

    Quantity

    35 Units