BEUDAMED
    FDA Recall Terminated

    Becton Dickinson's ProbeTec (tm) ET Instrument

    Recall: Z-1094-03 · Initiated July 21, 2003

    Recall

    Recall Number
    Z-1094-03
    Event Number
    26884
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    LSL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 21, 2003
    Posted
    August 20, 2003
    Terminated
    November 19, 2003
    Address
    7 Loveton Circle, Sparks, MD, 21152

    Description

    Becton Dickinson's ProbeTec (tm) ET Instrument

    Reason

    Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.

    Action

    The recalling firm notified consignees by letter on 7/21/2003 and advised of the potential for incorrect optical bundle installation. The firm provided an optical test procedure with materials to conduct an on site performance test. Consignees were instructed not to report patient results until optical performance has been verified. Firm will replace or repair failing instruments.

    Distribution

    Product was distributed to domestic and military end users nationwide and international distributors.

    Quantity

    1015 units