Events

Recall of ADVIA Chemistry XPT System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72391
  • Event Risk Class
    Class 2
  • Event Number
    Z-0755-2016
  • Event Initiated Date
    2015-10-07
  • Event Date Posted
    2016-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140892
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    Multiple software issues. auto start-up fail, calibration interval resets when a reagent blank is run, control definition screen assumes range defined is 2 sd, laboratory information system (lis) communication/laboratory automation (las) issue, printer driver resets, ise calibration ranges are too conservative for urine sodium, archiving and deletion may fail and workstation services may restart.
  • Action
    On October 7, 2015 Siemens Healthcare Diagnostics distributed Urgent Field Safety Notices to their custoemrs via Fed Ex in the U.S. and via email to regional countries for implementation outside of the U.S. Customers were provided a work-around if they have experienced any of the following problems: 1) Intermittent auto-startup function fails, 2) calibration interval resets as though a full calibration was performed, 3) Users may be unaware that the QC definition screen with +/- suggests a 2 Standard Deviation range value, 4) a rescanned and re-queried sample may become stuck in a communication loop and all tests may read as "inprocess" if the the initial reaction process is incomplete, 5) The printer stops printing if multiple printouts are requested in quick succession, 6) the ISE calibration for Urine Sodium (Na) may fail due to the ranges being set conservatively during development, 7) The automatic or manually started, archiving and deletion maintenance activity may fail and 8) A workstation services restart screen may appear under multiple scenarios causing the interface to be temporarily inaccessible. If customers have experienced any of the previously mentioned workflow problems, please perform the following actions: 1. Auto Start Failing: Manually perform the Startup Wash, run controls and any calibrations that are due. 2. Calibration interval resets when an RBL is run: Calibration should be run according to the recommendations in the Instructions for Use (IFU) for each assay. Keep a record of required calibrations and ensure that all assays are calibrated before use. 3. Control definition screen assumes that the range is defined as 2 SD values: When creating QC definitions, enter the values associated with a +/- 2 Standard Deviation (SD) range in the +/- ranges field.4. Laboratory Information System (LIS) communication / Laboratory Automation (LAS) issue: Be aware of errors in the event log and take action as needed. Manual intervention and rerunning

Device

ADVIA Chemistry XPT System
  • Model / Serial
    Software Version 1.0.3
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) in states of: AZ, CA, MA, NY, TX & WA, and to countries of: Bahrain, Egypt, Slovakia, France, Spain, Italy, Norway, Singapore, New Zealand, Germany, Australia, Republic Korea, Netherlands, Denmark, Finland & United Kingdom.
  • Product Description
    ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 || Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (ISE) tests per hour.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA