BEUDAMED
    FDA Recall 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 · Initiated June 13, 2013

    Recall

    Recall Number
    Z-1812-2013
    Event Number
    65619
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    MLA
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 13, 2013
    Posted
    July 26, 2013
    Terminated
    September 28, 2013
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    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.

    Action

    Becton Dickinson Diagnostic Systems notified distributors by fax on June 13, 2013, and advised consignees to discontinue use and discard affected product for credit. Distributors were requested to return their distribution list to BD for direct notification by the recaller. End users were contacted by letter on June 13, 2013 and the notification addressed to Microbiology Lab Director/Risk Managers advised that a small number of tests associated with the referenced lots of product may exhibit invalid internal negative control results. If encountered, the issue would result in an invalid test, as described in the package insert. End users were requested to discontinue use of these lot numbers, discard any remaining packages for replacement and return the enclosed response form. Customers with questions were instructed to contact BD Technical Services Department at 1-800-638-8663. For assistance regarding replacements customers were instructed to contact BD Customer Service at 1-800-675-0908. For questions regarding this recall call 410-316-4054.

    Distribution

    Nationwide Distribution

    Quantity

    177 kits