BEUDAMED
    FDA Recall Terminated

    Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.

    Recall: Z-0251-2013 · Initiated November 19, 2009

    Recall

    Recall Number
    Z-0251-2013
    Event Number
    63380
    Firm
    Sunquest Information Systems, Inc.
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 19, 2009
    Posted
    November 6, 2012
    Terminated
    November 6, 2012
    Address
    250 S Williams Blvd, Tucson, AZ, 85711-4472

    Description

    Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.

    Reason

    The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.

    Action

    Sunquest sent an "URGENT-PRODUCT SAFETY NOTICE: PSN-09-06" letter dated November 19, 2009 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were informed that Sunquest Application Interfacing would be contacting their facility for scheduling to correct the issue.

    Distribution

    Nationwide Distribution.

    Quantity

    9 units