BEUDAMED
    FDA Enforcement Class II Ongoing

    Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

    Recall: Z-1358-2024 · Reported April 3, 2024

    Enforcement

    Recall Number
    Z-1358-2024
    Event ID
    94020
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bio-Rad Laboratories
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 3, 2024
    Initiation Date
    February 15, 2024
    Classification Date
    March 22, 2024
    Address
    5731 W Las Positas Blvd, N/A, Pleasanton, CA, 94588-4084, United States

    Description

    Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

    Reason

    Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.

    Code Info

    Lot # 64562656 & 64571846/ UDI: 03610521162834

    Distribution

    US Nationwide distribution in the states of PA, SD, TX, FL, MN.

    Quantity

    33 units