BEUDAMED
    FDA Recall Terminated

    BD PhoenixSpec Nephelometer, Catalog #440910.

    Recall: Z-0443-06 · Initiated January 17, 2006

    Recall

    Recall Number
    Z-0443-06
    Event Number
    34396
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    JQX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 17, 2006
    Posted
    January 25, 2006
    Terminated
    May 5, 2006
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    BD PhoenixSpec Nephelometer, Catalog #440910.

    Reason

    A operator's manual for a diagnostic test kit is incorrect and may cause inaccurate results for bacterial identification and antibiotic susceptibility in patient samples.

    Action

    The recalling firm notified direct accounts by courier and international distributors by e-mail on 01/17/06. The notification advised that the the troubleshooting section in the firm''s nephelometer user''s guide, vers. 2004/12, is incorrect in describing the 'CAL?' message as indicating a default calibration is in use. The recalling firm provided a cautionary sticker in the bulletin and described recommended placement on the device by pictorial. The sticker instructs users not to use the nephelometer if 'CAL?' message appears on the units'' LCD screen.

    Distribution

    The devices were distributed to direct accounts nationwide and affiliated distributor facilities worldwide.

    Quantity

    488 units