BEUDAMED
    FDA Recall Terminated

    Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469

    Recall: Z-2913-2016 · Initiated September 2, 2016

    Recall

    Recall Number
    Z-2913-2016
    Event Number
    75108
    Firm
    Siemens Healthcare Diagnostics Inc
    FEI Number
    3002637618
    Product Code
    JFS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 2, 2016
    Posted
    September 30, 2016
    Terminated
    August 7, 2017
    Address
    2 Edgewater Dr, Norwood, MA, 02062-4637

    Description

    Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469

    Reason

    Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge

    Action

    Siemens Healthcare issued An Urgent Field Safety Notice via e-mail to affected Siemens Healthcare Diagnostics Regional offices on September 2, 2016 both in the United States and outside of the United States, for communication with affected customers e: the bias of the chloride values. US accounts sent hard copy via Federal Express and requested to: Complete and return the Field Correction Effectiveness Check form attached to this letter within 7 days. Review this letter with your Medical Director. Questions:Contact your Siemens Customer Care Center or your local Siemens technical support representative.

    Distribution

    Nationwide: Foreign: Canada, Bahamas,Germany, Japan, Mexico.Belgium, Italy,Spain, Korea, France, Austria, Korea, France, Poland, Australia, china, AE, Bangladesh, Columbia, Czechkoslovakia, Bosnia

    Quantity

    6638 cartridges