BEUDAMED
    FDA Recall Open, Classified

    Virus Counter Platform with Model Name VC3100

    Recall: Z-0946-2022 · Initiated March 11, 2022

    Recall

    Recall Number
    Z-0946-2022
    Event Number
    89818
    Firm
    Sartorius Corporation
    FEI Number
    3010058489
    Product Code
    REQ
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    March 11, 2022
    Address
    6542 Fig St, Arvada, CO, 80004-1042

    Description

    Virus Counter Platform with Model Name VC3100

    Reason

    The Virus Counter is an automated laboratory instrument that enables rapid quantification of intact viruses in solution. This instrument is not a medical device. The virus quantification is used in process development and manufacturing of various biotechnology products such as vaccines, gene therapy and personalized immunotherapy. Device is a Class 1 laser flow cytometer.

    Action

    Sartorius sent customer notification dated March 11, 2022 to all affected customers. Customers were informed that a field service personnel will be dispatch to update the labeling and provide an updated User Information manual (operator s manual) *. This work occurs at no cost to you regardless of scenario. You need only make the unit accessible for a few minutes for the representative to complete the upgrade.

    Distribution

    US Nationwide distribution.

    Quantity

    82