BEUDAMED
    FDA Recall Terminated

    Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***" The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data reduction and generate reports.

    Recall: Z-2201-2011 · Initiated July 19, 2010

    Recall

    Recall Number
    Z-2201-2011
    Event Number
    56389
    Firm
    Bio-Rad Laboratories
    FEI Number
    3008272466
    Product Code
    LFX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    July 19, 2010
    Posted
    May 19, 2011
    Terminated
    August 25, 2011
    Address
    6565 185th Ave NE, Redmond, WA, 98052-5039

    Description

    Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***" The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data reduction and generate reports.

    Reason

    The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.

    Action

    Bio-Rad Laboratories sent an Urgent Product Correction letter dated July 19, 2010, to all customer sites via FedEx. There are two issues related to The EVOLIS Assay Protocol Files (APF) Software that could potentially affect patient results. Issue 1 involves quantitative sample test/calculations/results interpretation for assays with linear regression, point to point or 4PL data reduction. Issue 2 involves sample test results with " Result Report Flags''. A software patch to correct these two issues will be sent to each customer site. Bio-Rad Laboratories will work with each customer to complete documentation confirming that the software patch has been successfully installed on each instrument. If you have any questions or concerns regarding these two issues, please contact Technical Support at 1-800-224-6723, option 2 and then option 3.

    Distribution

    Nationwide Distribution -- Including Puerto Rico.

    Quantity

    272