BEUDAMED
    FDA Recall Terminated

    i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer

    Recall: Z-0865-2010 · Initiated September 29, 2009

    Recall

    Recall Number
    Z-0865-2010
    Event Number
    53483
    Firm
    Abbott Point of Care Inc.
    FEI Number
    2245578
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 29, 2009
    Posted
    February 26, 2010
    Terminated
    July 1, 2010
    Address
    400 College Rd E, Princeton, NJ, 08540-6607

    Description

    i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer

    Reason

    Abbott Point of Care has determined that it is possible under certain circumstances that some test records could have their status update messages mis-matched with another record, resulting in the incorrect patient name, order number of comment being included in the CDS test record only.

    Action

    Urgent Recall Notification letters were sent by Fed Ex to all US customers on September 29, 2009 and worldwide on October 1, 2009. Questions should be directed to Abbott Point of Care Technical Support at 1-800-366-8010, Option 1.

    Distribution

    Nationwide and Foreign: Germany, the United Kingdom, Switzerland and the Netherlands.

    Quantity

    36