BEUDAMED
    FDA Enforcement Class II Ongoing

    therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)

    Recall: Z-2665-2023 · Reported October 11, 2023

    Enforcement

    Recall Number
    Z-2665-2023
    Event ID
    92991
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Qiagen GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 11, 2023
    Initiation Date
    August 22, 2023
    Classification Date
    September 29, 2023
    Address
    Qiagen Str. 1, N/A, Hilden, N/A, N/A, Germany

    Description

    therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)

    Reason

    Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be made to the S the sample result with this flag should be interpreted as invalid

    Code Info

    GTIN number: 04053228002048 All lots that have an expiry date of March 2023 or later

    Distribution

    Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN, KS, MA, NC,NY,OR, PA, TN, TX and the countries of KR, CN

    Quantity

    N/A