BEUDAMED
    FDA Enforcement Class II Terminated

    cobas¿ Liat¿ Analyzer

    Recall: Z-2216-2016 · Reported July 27, 2016

    Enforcement

    Recall Number
    Z-2216-2016
    Event ID
    74094
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Roche Molecular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 27, 2016
    Initiation Date
    May 9, 2016
    Classification Date
    July 15, 2016
    Termination Date
    March 24, 2021
    Address
    1080 US Highway 202 S, N/A, Branchburg, NJ, 08876-3733, United States

    Description

    cobas¿ Liat¿ Analyzer

    Reason

    Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.

    Code Info

    US-IVD: M1-E-00383 & M1-E-00434

    Distribution

    Distributed in NC and WA.

    Quantity

    2