BEUDAMED
    FDA Enforcement Class II Terminated

    BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species,

    Recall: Z-1812-2013 · Reported August 7, 2013

    Enforcement

    Recall Number
    Z-1812-2013
    Event ID
    65619
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 7, 2013
    Initiation Date
    June 13, 2013
    Classification Date
    July 26, 2013
    Termination Date
    September 28, 2013
    Address
    BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States

    Description

    BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species,

    Reason

    In vitro diagnostic test kit may exhibit invalid internal negative control results.

    Code Info

    Cat #446257: Lot 3035126 Exp 12/04/13 Cat #446252: Lot 3065261 Exp 08/31/13

    Distribution

    Nationwide Distribution

    Quantity

    177 kits