BEUDAMED
    FDA Recall Terminated

    cobas Liat Analyzer, for in vitro diagnostic use.

    Recall: Z-2543-2015 · Initiated July 24, 2015

    Recall

    Recall Number
    Z-2543-2015
    Event Number
    71785
    Firm
    Roche Molecular Systems, Inc.
    FEI Number
    2243471
    Product Code
    OCC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 24, 2015
    Posted
    September 2, 2015
    Terminated
    December 23, 2015
    Address
    1080 US Highway 202 S, Branchburg, NJ, 08876-3733

    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.

    Action

    Roche sent an Urgent Medical Device Recall letter dated July 24, 2015, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. Actions Required Identify the affected systems in your inventory by referencing the serial numbers in the table on page 1. You will be contacted to return affected systems for immediate replacement. Complete the attached fax form and fax it to 1-317-521-4815. File this UMDR for future reference. Please contact the Roche Support Network Customer Support Center cobas Liat hotline at 1-800-800-5973, if you have questions about the information contained in this letter.

    Distribution

    US Distribution to the states of :TX and NC.

    Quantity

    5 pieces