BEUDAMED
    FDA Enforcement Class II Terminated

    cobas Liat Analyzer, for in vitro diagnostic use.

    Recall: Z-2543-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2543-2015
    Event ID
    71785
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 9, 2015
    Initiation Date
    July 24, 2015
    Classification Date
    September 2, 2015
    Termination Date
    December 23, 2015
    Address
    1080 US Highway 202 S, N/A, Branchburg, NJ, 08876-3733, United States

    Description

    cobas Liat Analyzer, for in vitro diagnostic use.

    Reason

    Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers.

    Code Info

    Production Identifier (Lot/Serial Number): M1-E-00375, M1-E-00380, M1-E-00381, M1-E-00382, M1-E-00389

    Distribution

    US Distribution to the states of :TX and NC.

    Quantity

    5 pieces