BEUDAMED
    FDA Recall 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 · Initiated June 1, 2017

    Recall

    Recall Number
    Z-0198-2018
    Event Number
    78102
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    JQX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 1, 2017
    Terminated
    May 9, 2018
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    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

    Action

    BD Diagnostic Systems telephoned all customers on June 1, 2017 and sent an Urgent Product Recall letter dated May 31, 2017, and Response Forms to their customers via email. BD recently confirmed a manufacturing issue with the motor that drives movement of the robot arm. The issue may result in the inability of this motor to withstand the lateral forces encountered during normal operations. Should this occur, the instrument will indicate an E20 error-Pipettor step loss during operation and stop functioning. While there is no loss of patient sample, the samples would need to be manually processed until the instrument can be repaired. To limit any disruption in the workload, BD Service will contact customers to schedule the instrument replacement. Customers are advised to complete and return the response form via email to [email protected]. Customers may continue to use the instrument until replacement is performed. Customers with questions may contact BD (Customer/Technical) Support at 1-800-638-8663. For questions regarding this recall call 410-316-4258.

    Distribution

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

    Quantity

    7 units