BEUDAMED
    FDA Recall Terminated

    The Quidel Triage BNP Calibrators

    Recall: Z-0297-2021 · Initiated October 1, 2020

    Recall

    Recall Number
    Z-0297-2021
    Event Number
    86560
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    NBC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 1, 2020
    Terminated
    May 3, 2021
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    The Quidel Triage BNP Calibrators

    Reason

    Product compromised during shipment.

    Action

    On Oct 1st 2020, the firm sent a letter to its consignees with the following instructions: 1. Immediately check your stock for the affected item number and lots, listed on the attached destruction form. Quarantine all affected product. 2. Please return the completed enclosed destruction form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. Your account will receive credit when the destruction form is received. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication.

    Distribution

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

    Quantity

    26 devices