BEUDAMED
    FDA Recall Open, Classified

    QIAcube Connect MDx, Model No. 9003070

    Recall: Z-1746-2022 · Initiated November 21, 2021

    Recall

    Recall Number
    Z-1746-2022
    Event Number
    90758
    Firm
    Qiagen Sciences LLC
    FEI Number
    3003572099
    Product Code
    JJH
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    November 21, 2021
    Address
    19300 Germantown Rd, Germantown, MD, 20874-1415

    Description

    QIAcube Connect MDx, Model No. 9003070

    Reason

    During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, under diluted, or improperly lysed sample, which in turn could lead to false negative or false positive results.

    Action

    Customers were notified of the initial issue by email beginning Nov 3 2021, and requested to return acknowledgment of the notice. On January 26, 2022, a new version of the protocol software was released and customers were advised of the new protocol availability and acknowledge download via a follow up notice.

    Distribution

    Domestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN, NV, NJ, NY, NC, OH, PA, SC, SD, TN, TX, VA, WA, WI. International distribution worldwide.

    Quantity

    93 US; 57 OUS