BEUDAMED
    FDA Enforcement Class III Terminated

    Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161

    Recall: Z-2912-2016 · Reported October 12, 2016

    Enforcement

    Recall Number
    Z-2912-2016
    Event ID
    75108
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 12, 2016
    Initiation Date
    September 2, 2016
    Classification Date
    September 30, 2016
    Termination Date
    August 7, 2017
    Address
    2 Edgewater Dr, N/A, Norwood, MA, 02062-4637, United States

    Description

    Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161

    Reason

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

    Code Info

    Serial Numbers:2610900214 through 2621001325 Expiry Dates: Sept 13, 2016 through Dec. 6, 2016

    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

    689 cartridges