BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS Sodium Slides, Catalog # 837 9034

    Recall: Z-3280-2018 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-3280-2018
    Event ID
    80436
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 10, 2018
    Initiation Date
    May 5, 2018
    Classification Date
    September 28, 2018
    Termination Date
    February 19, 2021
    Address
    513 Technology Blvd, Rochester, NY, 14626-3601, United States

    Description

    VITROS Sodium Slides, Catalog # 837 9034

    Reason

    Potential for positively biased results

    Code Info

    UDI - 10758750004812 GENs- 8, 13, 14, 16, 17 & 18 Expiry Dates: 01-Nov-2018 through 01-Nov-2019

    Distribution

    US Nationwide, Bermuda, Austria, Brazil, Canada, Colombia, China, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium and the Netherlands