BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1358-2024 · Initiated February 15, 2024

    Recall

    Recall Number
    Z-1358-2024
    Event Number
    94020
    Firm
    Bio-Rad Laboratories
    FEI Number
    3010581187
    Product Code
    OYX
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 15, 2024
    Posted
    March 22, 2024
    Address
    5731 W Las Positas Blvd, Pleasanton, CA, 94588-4084

    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.

    Action

    On February 7, 2024, Bio-Rad issued their initial "Urgent Medical Device Correction" notification via E-Mail. On February 14, 2023, Bio RAD Laboratories issued a revised "Urgent Medical Device Correction" notification via E-Mail. Bio-Rad asked consignees to take the following actions: 1. Confirm past patient results against correct values for Catalog No. 12005560, Batch Nos. 64562656 and 64571846 when provided with corrected calibrator values by Bio-Rad Laboratories. 2. If all the controls values fall within the corrected ranges, no further action is required. If one or more controls are outside the corrected ranges, that particular run should be considered as failed and the results for the patient samples tested within that run should be considered invalid. 3. Please go to Bio-Rad.com for the updated Certificate of Analysis. 4. Please ensure this notice is passed to all those who need to be aware within your organization or to any organization where the impacted devices have been transferred. 5. Please complete and return the attached response form as soon as possible so that we are assured you have received this important communication. 6. This notice has been reported to the appropriate Regulatory Agencies. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

    Distribution

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

    Quantity

    33 units