BEUDAMED
    FDA Recall Terminated

    Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A. The software calculates and interprets assay results generated by the Digene Microplate Luminometer according to assay validation parameters. The software is used in conjunction with the following QIAGEN products: digene HC2 High-Risk HPV DNA Test [5199-1220 (one-plate); 5199-00016 (four-plate)] digene HC2 HPV DNA Test (5198-1220) digene HC2 CT/GC DNA Test (5130-1220) digene HC2 CT-ID DNA Test (5135-1220) digene HC2 GC-ID DNA Test (5140-1220) digene HC2 CT-GC Dual-ID DNA Test (5145-1220)

    Recall: Z-1728-2011 · Initiated January 12, 2011

    Recall

    Recall Number
    Z-1728-2011
    Event Number
    57814
    Firm
    QIAGEN Gaithersburg, Inc.
    FEI Number
    3003572099
    Product Code
    JJQ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 12, 2011
    Terminated
    November 14, 2011
    Address
    1201 Clopper Rd, Gaithersburg, MD, 20878-4000

    Description

    Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A. The software calculates and interprets assay results generated by the Digene Microplate Luminometer according to assay validation parameters. The software is used in conjunction with the following QIAGEN products: digene HC2 High-Risk HPV DNA Test [5199-1220 (one-plate); 5199-00016 (four-plate)] digene HC2 HPV DNA Test (5198-1220) digene HC2 CT/GC DNA Test (5130-1220) digene HC2 CT-ID DNA Test (5135-1220) digene HC2 GC-ID DNA Test (5140-1220) digene HC2 CT-GC Dual-ID DNA Test (5145-1220)

    Reason

    The software component of a diagnostic medical device may be defective and could cause incorrect patient values.

    Action

    The firm, Qiagen, sent a "Notice of Product Field Action" letter dated January 12, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue the process of running multiple assay protocols on a single microplate to eliminate the potential for inaccurate patient result reporting, and to complete and return the acknowledgment section via fax to QIAGEN 661-702-3854 or scan the document and email to [email protected]. The firm informed users that they will provide further detailed instructions for a workaround and software fix. A QIAGEN representative will contact the customers who indicated that they run multiple assays on a plate and are currently using the HC2 System Software Version 3.0 (Suite 4.0), to assist in the identification of those patients that may have been affected by the software defect. If you have any questions or concerns, please contact Qiagen Technical Services at 800-344-3631, Option 2.

    Distribution

    The recalled product was sold to medical laboratories nationwide and in Canada.

    Quantity

    163