BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic

    Recall: Z-0915-2018 · Reported March 14, 2018

    Enforcement

    Recall Number
    Z-0915-2018
    Event ID
    79155
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 14, 2018
    Initiation Date
    September 22, 2017
    Classification Date
    March 6, 2018
    Termination Date
    August 24, 2020
    Address
    1000 Lee Road, N/A, Rochester, NY, 14606, United States

    Description

    VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic

    Reason

    This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.

    Code Info

    Catalog# 6802331 Lot# M5620

    Distribution

    Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.

    Quantity

    102