BEUDAMED
    FDA Enforcement Class II Terminated

    Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry

    Recall: Z-2270-2012 · Reported September 5, 2012

    Enforcement

    Recall Number
    Z-2270-2012
    Event ID
    62708
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sunquest Information Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2012
    Initiation Date
    December 5, 2011
    Classification Date
    August 24, 2012
    Termination Date
    August 27, 2012
    Address
    250 S Williams Blvd, N/A, Tucson, AZ, 85711-4472, United States

    Description

    Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry

    Reason

    The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information.

    Code Info

    Versions 6.4 and later

    Distribution

    Worldwide Distribution -- USA (nationwide) and the country of Canada.

    Quantity

    127 sites