BEUDAMED
    FDA Recall Terminated

    BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19)

    Recall: Z-0321-05 · Initiated October 20, 2004

    Recall

    Recall Number
    Z-0321-05
    Event Number
    30443
    Firm
    BD Diagnostic Systems
    FEI Number
    1025402
    Product Code
    GSY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 20, 2004
    Posted
    December 16, 2004
    Terminated
    February 1, 2005
    Address
    1475 Athens Hwy, Grayson, GA, 30017-1538

    Description

    BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19)

    Reason

    Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions.

    Action

    Consignees were notified by letter beginning 10/20/2004.

    Distribution

    Nationwide, Australia, Belgium, Canada, Chile, Ecuador, India, Korea, Malaysia, New Zealand, Singapore, Taiwan

    Quantity

    100 vials (5ml per vial)