BEUDAMED
    FDA Recall Terminated

    AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20 The AxSYM Rubella IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum or plasma (EDTA, heparin or sodium citrate) to aid in the determination of immune status to rubella.

    Recall: Z-2175-2008 · Initiated June 2, 2008

    Recall

    Recall Number
    Z-2175-2008
    Event Number
    48626
    Firm
    Abbott Laboratories
    FEI Number
    1415939
    Product Code
    LFX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 2, 2008
    Posted
    September 16, 2008
    Terminated
    November 5, 2008
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    AxSYM Rubella IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; list 3B23-20 The AxSYM Rubella IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative and qualitative measurement of IgG antibodies to rubella virus in human serum or plasma (EDTA, heparin or sodium citrate) to aid in the determination of immune status to rubella.

    Reason

    An increase in complaints was noted for AxSYM Rubella IgG assay calibration failures due to error codes related to elevated Calibrator A (or Master Calibrator 1) rates too high.

    Action

    Consignees were sent a Product Correction-Immediate Action Required letter on 6/2/08. The letter informed users of calibration failures due to elevates Calibrator A or Master Calibrator 1 rates when attempting to calibrate the AxSYM Rubella IgG assay and that they must clarify the Rubella IgG Calibrator A or the Rubella IgG Master Calibrator 1 and the Rubella IgG Negative Control by centrifugation at >/= 10,000 x g for 10 minutes prior to testing. Users were requested to return a customer reply letter acknowledging receipt of the letter. For additional information, contact Abbott Labs at 1-877-4ABBOTT.

    Distribution

    Worldwide Distribution including USA, territory of Puerto Rico, and countries of Australia, Bahamas, Canada, Chile, Colombia, Costa Rica, Curacao, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, Jamaica, Mexico, Peru, New Zealand, Panama, Singapore, South Korea, Thailand, Turks & Caicos and Uruguay.

    Quantity

    33,485 reagent kits