BEUDAMED
    FDA Recall Terminated

    Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry

    Recall: Z-2270-2012 · Initiated December 5, 2011

    Recall

    Recall Number
    Z-2270-2012
    Event Number
    62708
    Firm
    Sunquest Information Systems, Inc.
    FEI Number
    1000306472
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 5, 2011
    Posted
    August 24, 2012
    Terminated
    August 27, 2012
    Address
    250 S Williams Blvd, Tucson, AZ, 85711-4472

    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.

    Action

    Sunquest sent a recall letter dated December 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your reply to this email message serves as verification you have received, read, understood and/or followed instructions outlined in the attached Product Safety Notification. Your reply assists Sunquest Information Systems to satisfy our obligation to Regulatory Agencies. Please note in your email reply if your site will not be requesting the software correction. If your site plans to request the software correction, please follow the directions noted on the attached PSN. Further questions please call (520) 570-2347.

    Distribution

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

    Quantity

    127 sites