BEUDAMED
    FDA Recall Terminated

    QIAamp DSP Virus Kit Cat. No. 60704

    Recall: Z-0274-2018 · Initiated July 22, 2017

    Recall

    Recall Number
    Z-0274-2018
    Event Number
    78646
    Firm
    Qiagen, GmbH Qiagen Str. 1 Hilden Germany
    FEI Number
    3004013603
    Product Code
    N/A
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 22, 2017
    Terminated
    July 26, 2018

    Description

    QIAamp DSP Virus Kit Cat. No. 60704

    Reason

    Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance.

    Action

    Qiagen sent ffected customers and commercial partners "Urgent Notice of Product Field Action", dated June 22, 2017 via an e-mail containing a letter as pdf. In the letter, customers were informed of the reason for recall, with an overview of affected products, detailed description of issue, consequences of the issue, actions to be taken by the customer/user, completion of the acknowledgement of receipt form, contact information and the commercial partners are instructed to forward , actions that have been initiated by AIAGEN, the letter to their customers.

    Distribution

    AR; AT; BE; CH; CN; CZ; DE; ES; FR; GB; GR; HK; IN; IR, IT; KR; MX; NL; NP, PH; PK; PL; TR, TW; US; UY, VN

    Quantity

    555