BEUDAMED
    FDA Recall Terminated

    ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes.

    Recall: Z-0183-2016 · Initiated August 28, 2015

    Recall

    Recall Number
    Z-0183-2016
    Event Number
    72104
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JGS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 28, 2015
    Terminated
    May 22, 2018
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes.

    Reason

    ISE module may produce discrepant, unflagged results for Sodium, Potassium or Chloride when the respective electrode is left unplugged after replacement, washing or maintenance activities. The calibration and 2-level QC will fail if the electrode is left unplugged. The IFU states to calibrate the ISEs after replacement and to run two levels of controls before running patient samples.

    Action

    Urgent Medical Device Correction letters (dated 8/27/2015) and Field Correction Effectiveness Check Forms were sent to customers via FedEx starting on 8/28/2015, informing them of the potential for discrepant ISE results. Customers must follow the instructions provided in the letter. The Actions to Be Taken section of the letter notes that customers must ensure that the electrodes are fully plugged in after replacement, washing or maintenance activities, followed by performing an ISE Calibration and running 2 levels of Quality Control material. Urgent Field Safety Notices were sent to customers outside the USA. The Field Correction Effectiveness Check form should have been completed and returned. A copy of the letter should be kept with laboratory records; and, the letter should be forwarded to anyone who may have received the affected product. Customers should contact their Siemens Customer Care Center or their local Siemens technical support representative with questions.

    Distribution

    Worldwide Distribution -- US, Australia, Bahrain, Denmark, Egypt, Egypt, Finland, France, Germany, Italy, Netherlands, New Zealand, Norway, Republic Korea, Singapore, Slovakia, Spain, and the United Kingdom.

    Quantity

    Domestic: 15 units; Foreign: 59 units