BEUDAMED
    FDA Enforcement Class II Terminated

    Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001

    Recall: Z-2477-2019 · Reported September 11, 2019

    Enforcement

    Recall Number
    Z-2477-2019
    Event ID
    83525
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Diagnostics Operations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2019
    Initiation Date
    July 18, 2019
    Classification Date
    September 5, 2019
    Termination Date
    June 15, 2020
    Address
    9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States

    Description

    Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001

    Reason

    Quality issue with high pressure solenoid valves

    Code Info

    cobas c 701 module Serial # : 19P2-01, 1390-03, 1139-04, 1139-05, 1139-06. cobas c 702 module serial # : 1126-03, 1237-10, 14C2-04 cobas¿ 8000 ISE module serial # : 1943-01, 1943-02, 1943-03, 1943-04, 1943-05, 1943-06, 1943-07, 1943-08, 1943-09, 1943-10, 15B3-05.

    Distribution

    State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK

    Quantity

    19 units