BEUDAMED
    FDA Enforcement Class III Terminated

    BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required for preparing samples for use on the BD Phoenix" system, which performs identification and susceptibility testing

    Recall: Z-0198-2018 · Reported December 13, 2017

    Enforcement

    Recall Number
    Z-0198-2018
    Event ID
    78102
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 13, 2017
    Initiation Date
    June 1, 2017
    Classification Date
    December 6, 2017
    Termination Date
    May 9, 2018
    Address
    7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States

    Description

    BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required for preparing samples for use on the BD Phoenix" system, which performs identification and susceptibility testing

    Reason

    Potential unexpected movement of robot arm

    Code Info

    Serial Numbers: AP0447, AP0448, AP0449, AP0450, AP0451, AP0458 & AP0463.

    Distribution

    Worldwide Distribution - US including CA, NC & TN Internationally: Canada

    Quantity

    7 units