BEUDAMED
    FDA Recall Terminated

    BD PhoenixSpec Calibrator Kit, consisting of 3 tubes identified as 0.25, 1.0 and 4.0 McFarland unit calibrators, and labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA***

    Recall: Z-0430-06 · Initiated December 1, 2005

    Recall

    Recall Number
    Z-0430-06
    Event Number
    34202
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    JQX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 1, 2005
    Posted
    January 24, 2006
    Terminated
    April 6, 2006
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    Description

    BD PhoenixSpec Calibrator Kit, consisting of 3 tubes identified as 0.25, 1.0 and 4.0 McFarland unit calibrators, and labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA***

    Reason

    A calibrator for an in vitro diagnostic kit is not standarized correctly and may cause a calibration error when measuring microbiological cultures for turbidity.

    Action

    The recalling firm notified consignees by phone, fax and e-mail on 12/01/05. The notification advised that nephelometers displaying 'CAL' error messages on the LED should not be used until calibrated with a different kit lot. Consignees were requested to discard referenced lots for replacement. A response form was included in the notification.

    Distribution

    Product was sold to direct accounts nationwide and international affiliated distributors in Japan, Belize, Taiwan, Canada, Korea, Australia, and the Philippines.

    Quantity

    145 kits