BEUDAMED
    FDA Enforcement Class II Terminated

    The Quidel Triage BNP Calibrators

    Recall: Z-0297-2021 · Reported November 4, 2020

    Enforcement

    Recall Number
    Z-0297-2021
    Event ID
    86560
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 4, 2020
    Initiation Date
    October 1, 2020
    Classification Date
    October 26, 2020
    Termination Date
    May 3, 2021
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    The Quidel Triage BNP Calibrators

    Reason

    Product compromised during shipment.

    Code Info

    Model Number: ALR98202 Expiration date: Lot 832243, exp date 12/31/19 Lot 832570, exp date 03/31/20 Lot 921292, exp date 08/31/20 Lot 921565, exp date 12/31/20 Lot 921836, exp date 02/28/21 Lot 922069, exp date 03/31/21

    Distribution

    Domestic Distribution only to: CA, NY, TX and VA

    Quantity

    26 devices