Events

Recall of Device Recall ADVIA XPT Chemistry 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
    70591
  • Event Risk Class
    Class 2
  • Event Number
    Z-1399-2015
  • Event Initiated Date
    2015-02-11
  • Event Date Posted
    2015-04-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134088
  • 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
    Electrode, ion specific, sodium - Product Code JGS
  • Reason
    Siemens healthcare diagnostics has confirmed an issue with advia chemistry xpt software version 1.0.2. the system may cause samples to remain in an inprocess state. test results on a sample that is held inprocess will not transmit to the lis. manual intervention is necessary to complete the processing of the samples that are held inprocess.
  • Action
    Siemens Healthcare Diagnostics sent Urgent Medical Device Correction Letters (dated 2/11/2015) via FedEx to the domestic consignees informing users of the software issue with ADVIA Chemistry XPT Software Version 1.0.2. The letters included work instructions to handle the bug. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within 30 days. For questions about in process samples, the event message 02 981 8728, or need assistance with mitigation solutions, please contact your Siemens Customer Care Center or your local Siemens Technical Support Representative. Urgent Field Safety Notice Letters were sent to the foreign consignees (distribution is determined at the country level). Field service personnel were notified of the Urgent Medical Device Correction Letter.

Device

Device Recall ADVIA XPT Chemistry System
  • Model / Serial
    Software Version 1.0.2; Lot Numbers: CA1275000080008, CA1275000090009, CA1275000060006, CA1275000050005, CA1275000070007, CA1275000130013, CA1275000100010, CA1275000120012, CA1275000170017, CA1275000260026, CA1275000270027, CA1275000280028, CA1275000240024, CA1275000200020, CA1275000220022, CA1275000410041
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of AZ, CA, and WA, and the countries of Germany, Italy, Spain, and UK.
  • Product Description
    ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Material Number 11219493, IVD. || The ADVIA XPT Chemistry System is an automated, 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