BEUDAMED
    FDA Enforcement Class II Terminated

    Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin A in the sample.

    Recall: Z-1988-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-1988-2019
    Event ID
    83189
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Laboratories, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2019
    Initiation Date
    May 16, 2018
    Classification Date
    July 19, 2019
    Termination Date
    August 16, 2021
    Address
    1921 Hurd Dr, N/A, Irving, TX, 75038-4313, United States

    Description

    Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 700 nm, which correlates with the concentration of immunoglobulin A in the sample.

    Reason

    An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

    Code Info

    All IFU's

    Distribution

    Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Chile, China, Costa Rica, Croatia, Curacao (Netherlands Antilles), Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Greenland, Honduras, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya. Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, Tunisia, UAE, United Kingdom, Uruguay, and Viet Nam.

    Quantity

    12,995 kits