BEUDAMED
    FDA Recall 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 · Initiated July 19, 2017

    Recall

    Recall Number
    Z-3138-2017
    Event Number
    77916
    Firm
    Kamiya Biomedical Company, LLC
    FEI Number
    2084025
    Product Code
    JIX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 19, 2017
    Terminated
    November 20, 2018
    Address
    12779 Gateway Dr S, Tukwila, WA, 98168-3308

    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.

    Action

    Kamiya Biomedical Company sent an Urgent Medical Device Recall/Correction Notice on July 14, 2017 to affected customers, providing them with updated package inserts with corrected A1AT values and/or free replacement kits. Customers were asked to fill in and return the acknowledgement form. Customers with questions were instructed to contact the firm at 206-575-8068.

    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