BEUDAMED
    FDA Recall Terminated

    BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***

    Recall: Z-0523-2013 · Initiated October 22, 2012

    Recall

    Recall Number
    Z-0523-2013
    Event Number
    63723
    Firm
    Becton Dickinson & Co. BD Diagnostic Systems
    FEI Number
    1119779
    Product Code
    GRO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 22, 2012
    Posted
    December 13, 2012
    Terminated
    January 24, 2013
    Address
    7 Loveton Circle, Sparks, MD, 21152-0999

    Description

    BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***

    Reason

    In vitro diagnostic test kit was not manufactured according to specifications and may cause false negatives or misidentification of Hemophilus species present in patient specimens.

    Action

    BD Diagnostic Systems sent an Urgent Product Recall letter dated October 22, 2012, to all affected customers.. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to discontinue distribution and discard affected inventory for credit. . Customers were requested to return a response form by fax to 410-316-4258. For questions customers were instructed to contact BD Customer Service Department at 1-800-638-8663. For assistance with replacements, customers were instructed to call 1-800-675-0908. For questions regarding this recall call 410-316-4258.

    Distribution

    Worldwide Distribution - USA (nationwide) to international customers in Belgium, India, Japan, South Korea, Thailand and Mexico

    Quantity

    650 vials