BEUDAMED
    FDA Recall Open, Classified

    QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1

    Recall: Z-2353-2024 · Initiated June 3, 2024

    Recall

    Recall Number
    Z-2353-2024
    Event Number
    94836
    Firm
    Qiagen Sciences LLC
    FEI Number
    3003572099
    Product Code
    JJH
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    June 3, 2024
    Posted
    July 12, 2024
    Address
    19300 Germantown Rd, Germantown, MD, 20874-1415

    Description

    QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1

    Reason

    Heater shaker module does not perform heating if the temperature is set below 40C for static incubation steps when running IVD protocol QIAamp DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filename: Kt_name_Bacteria (Gram+) or rY'east_Enzymatic Lysis_ V2) which could potentially cause delayed or erroneous results depending on the downstream assay.

    Action

    Qiagen issued Urgent Medical Device Correction Letter to Lab Director/Manager, Medical Director, Risk Manager, Safety Officer via email on June 3, 2024. Letter states reason for recall, health risk and action to take: l Complete the Acknowledgment of Receipt promptly and return to [email protected] l If running the above protocols and you have selected an incubation temperature for the bacterial lysis below 40C, then you can ensure precise temperature control by using the heater shaker built into the QIAcube Connect MDx via the Tools menu of the software. If you wish to check the actual applied temperature in your workflow as currently used, we offer to analyze your logfiles to determine the actual applied temperature. This may help you to confirm these settings. Please contact QIAGEN Technical Services at (800 362 7737) for assistance,

    Distribution

    Nationwide. Foreign: AD, AT, AU, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, ID, IN, IT, JO, KR, KZ, LU, ML, MY, NL, NO, PH, PL, PY, SA, SE, SG, SK, SO, VN J, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI

    Quantity

    419 units