BEUDAMED
    FDA Enforcement Class II Ongoing

    Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410

    Recall: Z-0981-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-0981-2024
    Event ID
    93724
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2024
    Initiation Date
    November 21, 2023
    Classification Date
    February 5, 2024
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037, United States

    Description

    Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410

    Reason

    There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive Insulin APF applies an incorrect conversion factor when converting from system default units of ¿IU/mL to the International System of Units (SI units) of pmol/L.

    Code Info

    UDI/DI 15099590230623, Lot Numbers: 125533, 125589, 233656, 233919, 234055, 234339, 234388

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Croatia, Czech Republic, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.

    Quantity

    19,125 reagent packs