BEUDAMED
    FDA Enforcement Class III Terminated

    cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.

    Recall: Z-1927-2019 · Reported July 10, 2019

    Enforcement

    Recall Number
    Z-1927-2019
    Event ID
    82651
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 10, 2019
    Initiation Date
    April 4, 2019
    Classification Date
    July 2, 2019
    Termination Date
    May 12, 2020
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.

    Reason

    There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.

    Code Info

    Serial Numbers - 1001 through 1044

    Distribution

    US Nationwide Distribution in the states of AL, CA, FL, IA, IL, KY, MD, OR & PA

    Quantity

    4 units