BEUDAMED
    FDA Recall Open, Classified

    Verigene EP Amplification Reagent Kit Test

    Recall: Z-2451-2021 · Initiated August 3, 2021

    Recall

    Recall Number
    Z-2451-2021
    Event Number
    88423
    Firm
    Luminex Corporation
    FEI Number
    3006028115
    Product Code
    PCH
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 3, 2021
    Address
    4088 Commercial Ave, Northbrook, IL, 60062-1829

    Description

    Verigene EP Amplification Reagent Kit Test

    Reason

    There is potential for false positive results.

    Action

    A customer letter was issued to notify consignees of the recall dated 08/03/2021. Customers are advised to notify Luminex if they are impacted by the recall and Luminex will facilitate replacement of the product. Customers are asked to destroy impacted product and document actions on a return response form.

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey.

    Quantity

    4579 kits