BEUDAMED
    FDA Enforcement Class II Ongoing

    Virus Counter Platform with Model Name VC3100

    Recall: Z-0946-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0946-2022
    Event ID
    89818
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Sartorius Corporation
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    April 27, 2022
    Initiation Date
    March 11, 2022
    Classification Date
    April 15, 2022
    Address
    6542 Fig St, Arvada, CO, 80004-1042, United States

    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.

    Code Info

    Model Numbers VIR-92166, VIR-92341

    Distribution

    US Nationwide distribution.

    Quantity

    82