BEUDAMED
    FDA Recall Terminated

    BD Vacutainer Microtainer Serum tubes (with or without gel).

    Recall: Z-1603-05 · Initiated August 20, 2004

    Recall

    Recall Number
    Z-1603-05
    Event Number
    30104
    Firm
    Becton Dickinson & Company
    FEI Number
    2243072
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 20, 2004
    Posted
    October 28, 2004
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815

    Description

    BD Vacutainer Microtainer Serum tubes (with or without gel).

    Reason

    "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and

    Action

    The firm sent out a Technical Bulletin to all consignees of the specific instrument companies involved. Mailing initial were done 9/17/2004 and a revised mailing was sent 9/23/2004. Global communication will commense 10/5/2004.

    Distribution

    Worldwide distribution.

    Quantity

    There is no linkage to any particular lot of BD product