BEUDAMED
    FDA Enforcement Class III Terminated

    Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

    Recall: Z-0308-2018 · Reported January 10, 2018

    Enforcement

    Recall Number
    Z-0308-2018
    Event ID
    78613
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 10, 2018
    Initiation Date
    November 6, 2017
    Classification Date
    January 3, 2018
    Termination Date
    November 4, 2019
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

    Reason

    Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.

    Code Info

    Serial/Lot Numbers: 570005-570043, 570047-570049, 570051-570061, 570066-570071, 570073-570091, 570093-570123, 570125, 570126, 570128, 570131-570153, 570156-570203, 570205-570241, 570244-570248, 570250-570252 and 512684

    Distribution

    Worldwide Distribution -- US, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey, United Kingdom, and Vietnam.

    Quantity

    227 units