BEUDAMED
    FDA Recall Terminated

    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.

    Recall: Z-0723-2017 · Initiated October 21, 2016

    Recall

    Recall Number
    Z-0723-2017
    Event Number
    75652
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 21, 2016
    Terminated
    June 7, 2018
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.

    Reason

    Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology System database that occurred during the installation of the systems. The database should only contain one record of a Sample ID number for any given time and date. If there are multiple records for the same Sample ID, it is possible that multiple results may be manually or automatically sent to the Laboratory Information System (LIS), printed or displayed on the results report screen.

    Action

    An Urgent Medical Device Correction Letter HI17-02.A.US (dated October 21, 2016) and Response Form were sent to US Customers via Federal Express. An Urgent Field Safety Notice was sent to customers outside the US on October 21, 2016, (distribution is determined at the country level). The letters instruct customers to contact their local Siemens technical support representative if they obtain multiple results for one Sample ID. It also informs the customer what to do if the ADVIA 560 Hematology System generates any of the six error messages listed in the letter. For further questions, please call (312) 275-7795.

    Distribution

    Worldwide Distribution - US Distribution to the states of including Puerto Rico and : CA, CO, FL, IL, MI, NJ, NY, OH, TX, WA, WI, WI and WY., and to the countries of : Angola, Australia, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, France, Germany, Greece, India, Italy, Japan, Kenya, Malaysia, Mexico, Myanmar, Netherlands, Norway, Pakistan, Portugal, Saudi Arabia, Slovenia, Spain, Switzerland, Turkey, Uganda, United Kingdom, Vietnam.

    Quantity

    US: 23 systems; Foreign: 141 systems