BEUDAMED
    FDA Recall Terminated

    cobas Liat Analyzer

    Recall: Z-2216-2016 · Initiated May 9, 2016

    Recall

    Recall Number
    Z-2216-2016
    Event Number
    74094
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    OCC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 9, 2016
    Terminated
    March 24, 2021
    Address
    1080 US Highway 202 S, Branchburg, NJ, 08876-3733

    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.

    Action

    Customers were notified of the recall via phone and email sent on 5/9/2016. They were instructed to take the following actions: Immediately discontinue use of the affected instruments until they have been reworked by a Roche Field Engineering Specialist. A Roche representative will contact you to schedule this service. Complete the attached fax form and fax it to 1-317-521-4815. File this Urgent Medical Device Correction (UMDC) for future reference. Please contact the Roche Support Network Customer Support Center 1-800-800-5973 if you have questions.

    Distribution

    Distributed in NC and WA.

    Quantity

    2