BEUDAMED
    FDA Enforcement Class II Terminated

    RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.

    Recall: Z-1249-2021 · Reported March 24, 2021

    Enforcement

    Recall Number
    Z-1249-2021
    Event ID
    87232
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 24, 2021
    Initiation Date
    January 25, 2021
    Classification Date
    March 12, 2021
    Termination Date
    January 9, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.

    Reason

    Product was compromised during shipment.

    Code Info

    lot number 072564

    Distribution

    US Nationwide distribution in the states of KY, PA, OH.

    Quantity

    4 units