BEUDAMED
    FDA Enforcement Class II Terminated

    K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG, lgM, and Transferrin immunoturbidimetric assays. For in vitro diagnostic use

    Recall: Z-3138-2017 · Reported September 27, 2017

    Enforcement

    Recall Number
    Z-3138-2017
    Event ID
    77916
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kamiya Biomedical Company, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 27, 2017
    Initiation Date
    July 19, 2017
    Classification Date
    October 20, 2017
    Termination Date
    November 20, 2018
    Address
    12779 Gateway Dr S, N/A, Tukwila, WA, 98168-3308, United States

    Description

    K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG, lgM, and Transferrin immunoturbidimetric assays. For in vitro diagnostic use

    Reason

    The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.

    Code Info

    Lot Numbers: N653, N654, D755, D647, F648, F649, G650, J651, L652

    Distribution

    Worldwide Distribution - US including FL, CA, WA, OH, IA, IL, NJ, NY, NC, MA, TX, CT, MD, VA, Internationally to TN, Czech Republic, Taiwan, Dominican Republic, Switzerland, China, and Jamaica

    Quantity

    1398 units