BEUDAMED
    FDA Enforcement Class II Terminated

    Control, Calibrator Verified, Triage BNP, Model ALR88755

    Recall: Z-3054-2020 · Reported October 7, 2020

    Enforcement

    Recall Number
    Z-3054-2020
    Event ID
    86258
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 7, 2020
    Initiation Date
    July 28, 2020
    Classification Date
    September 30, 2020
    Termination Date
    February 13, 2023
    Address
    Three Lakes Drive, N/A, Northfield, IL, 60093, United States

    Description

    Control, Calibrator Verified, Triage BNP, Model ALR88755

    Reason

    Product was shipped with refrigeration (ice) instead of frozen (dry ice).

    Code Info

    Lot Number and/or Serial Number: 30718, 407522, 420694, 422646, 430000, 422647N, 422648N, 428255N,428256N, 441421N, 441422N, 441423N

    Distribution

    Distribution in US - AR, AZ, CO, FL, MD, MS, MI, NC, NM, NY, OK, PA, RI, TX

    Quantity

    118 units