BEUDAMED
    FDA Recall Terminated

    ADVIA Centaur XPT Immunoassay System

    Recall: Z-0072-2017 · Initiated April 28, 2016

    Recall

    Recall Number
    Z-0072-2017
    Event Number
    74162
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JLW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 28, 2016
    Terminated
    June 7, 2018
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    ADVIA Centaur XPT Immunoassay System

    Reason

    The ADVIA Centaur XPT default setting for the Daily Maintenance Task (Daily Cleaning Procedure) frequency may have the Daily Maintenance Task frequency set to, As needed instead of Daily. Not performing the daily maintenance may impact any assay and can be detected through monitoring of quality control and calibration results. Systems running in a language other than English are not impacted.

    Action

    Siemens sent an Urgent Medical Device Correction letter dated April 28, 2016, to all affected customers. The letter advised customers not to release results generated by the system if quality control results are not within acceptable ranges. Customers were advised to perform the following steps to check the Setting for the Daily Maintenance Task frequency on your instrument: *Open the Maintenance Tab, * Select Daily Maintenance task and * Verify that the Frequency Column is set to "Daily at..". The Daily Maintenance Task frequency setting can only be reset by a Siemens Customer Service engineer. If your instrument is set to "As Needed": Daily Maintenance Task Frequency Setting May be Incorrect. Customers should contact their local Technical Support Center to schedule a visit by your Siemens Customer Service engineer. Customers should also perform the daily maintenance by selecting the Daily Maintenance Task and then selecting Perform on the right bar. In addition, all customers were asked to complete and return the Field Correction Effectiveness Check within 30 days. For questions regarding this recall call 914-631-8000.

    Distribution

    Worldwide Distribution - US including MD, MN, & MS; **Internationally** AE, AT, AU, BE, BR, CA, CN, DE, DK, EG, ES, FI, FR, GB, GP, HU, IN, IT, JO, JP, KR, MY, NO, NZ, PH, PT, QA, SA, SE, SG, TR & VN

    Quantity

    292 units Total (3 domestically & 289 internationally)