BEUDAMED
    FDA Enforcement Class II Terminated

    Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.

    Recall: Z-0297-2016 · Reported November 25, 2015

    Enforcement

    Recall Number
    Z-0297-2016
    Event ID
    72427
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 25, 2015
    Initiation Date
    September 22, 2015
    Classification Date
    November 18, 2015
    Termination Date
    February 3, 2016
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.

    Reason

    Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.

    Code Info

    During transport from the Bulk Loader Module (BLM), catalog number 07135645001, to the cobas p 512/p 612 pre-analytical instruments, sample tubes may inadvertently open and spill, causing contamination of the system.

    Distribution

    Distributed to TX only.

    Quantity

    1