BEUDAMED
    FDA Enforcement Class II Terminated

    VITROS Chemistry Products COCM Reagent

    Recall: Z-0817-2014 · Reported January 29, 2014

    Enforcement

    Recall Number
    Z-0817-2014
    Event ID
    66474
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2014
    Initiation Date
    October 4, 2013
    Classification Date
    January 23, 2014
    Termination Date
    May 17, 2018
    Address
    100 Indigo Creek Dr, Rochester, NY, 14626-5101, United States

    Description

    VITROS Chemistry Products COCM Reagent

    Reason

    Inaccurate quality control results.

    Code Info

    Product Code: 6801995; Lot numbers: 1) 1525-09-2754 Exp Date: 1 Nov 2013, 2) 1525-10-2091 Exp Date: 1 March 2014, 3) 1525-10-3062; Exp Date: 1 April 2014

    Distribution

    Worldwide Distribution. US nationwide (including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico), Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.

    Quantity

    3,342 units