BEUDAMED
    FDA Enforcement Class II Terminated

    BD AffirM VPIII Microbial Identification Test

    Recall: Z-1394-2017 · Reported March 8, 2017

    Enforcement

    Recall Number
    Z-1394-2017
    Event ID
    76492
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 8, 2017
    Initiation Date
    August 27, 2015
    Classification Date
    March 2, 2017
    Termination Date
    March 6, 2017
    Address
    7 Loveton Cir, BD Diagnostic Systems, Sparks, MD, 21152-9212, United States

    Description

    BD AffirM VPIII Microbial Identification Test

    Reason

    BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert.

    Code Info

    Catalog Number Batch Number 446252 5126980 5135673 5138774 5140625 5142767 5153674 5153675 5224882 446257 5141655 5148857 5156873 5173648

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY and to the countries of : AU, BE, IN, KR, SG,

    Quantity

    Qty Distributed to Field - 4,502