BEUDAMED
    FDA Recall Terminated

    BD AffirM VPIII Microbial Identification Test

    Recall: Z-1394-2017 · Initiated August 27, 2015

    Recall

    Recall Number
    Z-1394-2017
    Event Number
    76492
    Firm
    Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    MLA
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 27, 2015
    Posted
    February 27, 2017
    Terminated
    March 6, 2017
    Address
    Sparks, MD, 21152-9212

    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.

    Action

    Becton Dickinson sent an Urgent Product Recall Letter dated August 2015. The distributors were provided with a written communication via email and customers were provided with a written communication via UPS. Customers were not asked to send product back. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663. For further questions please call (410) 316-4428.

    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