BEUDAMED
    FDA Recall Terminated

    ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.

    Recall: Z-0011-2014 · Initiated August 12, 2013

    Recall

    Recall Number
    Z-0011-2014
    Event Number
    65898
    Firm
    Siemens Healthcare Diagnostics
    FEI Number
    2432235
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 12, 2013
    Posted
    October 17, 2013
    Terminated
    November 18, 2015
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.

    Reason

    Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide, it is possible that the next slide processed by the Autoslide could be labeled with the wrong sample identification information.

    Action

    Siemens sent an Urgent Medical Device Correction Letter dated August 8, 2013, and Effectiveness Checks Forms were sent to customers on August 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised if they do not have an ADVIA Autoslide connected to their system, no action is required. To avoid the possibility of mislabeling a slide when an ADVIA 2120/2120i rack jam error occurs: Eject the sample rack. Troubleshoot and correct the reason for the rack jam error. Rerun the sample rack. Field service personnel were sent a support bulletin describing the issue and instructing them how to deal with customer questions. If you need additional assistance, please contact Global Product Support Tarrytown, New York @ [email protected]

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Greece, Italy, Japan, Malaysia, Netherlands, Norway, Philippines, Portugal, South Korea, Singapore, Slovenia, Spain, Switzerland, Thailand, Turkey, United Kingdom and Vietnam.

    Quantity

    311 units total (US: 51 units; Foreign: 260 units)