BEUDAMED
    FDA Recall Open, Classified

    QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It is intended to be used only in combination with QIAsymphony kits indicated for use with the QIAsymphony SP for the applications described in the kit handbooks. The QIAsymphony SP is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAsymphony SP instrument

    Recall: Z-2319-2019 · Initiated July 2, 2019

    Recall

    Recall Number
    Z-2319-2019
    Event Number
    83409
    Firm
    Qiagen Sciences LLC
    FEI Number
    3003572099
    Product Code
    JJH
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    July 2, 2019
    Address
    19300 Germantown Rd, Germantown, MD, 20874-1415

    Description

    QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It is intended to be used only in combination with QIAsymphony kits indicated for use with the QIAsymphony SP for the applications described in the kit handbooks. The QIAsymphony SP is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAsymphony SP instrument

    Reason

    QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate ID to the sample within the results file. If 2D bar code eluate IDs are not checked against the sample ID prior to downstream application the incorrect tube may be selected and it could have the potential to lead to delayed results or incorrect patient reporting

    Action

    Qiagen notified Customer on July 2, 2019 via email and provided reason for recall, heath risk and action to take: Discontinue use of the workflow in the following specific condition: QIAsymphony software version 5.0.3 when using the 2D bar code integration feature with continuous loading. Please note that the 2D bar code labware, continuous loading, and Software 5.0.3 can still be used independently of the integration feature. Complete and sign the included Acknowledgement of Receipt form and email it to QIAGEN Technical Services at [email protected] or fax it to +49 (0)2103-29-22400. Questions, please contact QIAGEN Technical Services Department. Telephone: 800 362 7737. Email: [email protected]

    Distribution

    Worldwide Distribution - US Nationwide Foreign: Algeria Australia Austria Azerbaijan Belgium Brazil Canada China Czech Republic Denmark Finland France Germany Greece India Israel Italy Japan Jordan Korea, Republic of Kuwait Latvia Mexico Netherlands Norway Pakistan Poland Republic of Korea Russian Federation Singapore South Africa Spain Sweden Switzerland Thailand Turkey United Kingdom

    Quantity

    417