Events

Recall of Device Recall Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems

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
    67030
  • Event Risk Class
    Class 2
  • Event Number
    Z-0800-2014
  • Event Initiated Date
    2013-12-17
  • Event Date Posted
    2014-01-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124573
  • 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
    An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result.
  • Action
    The distribution of the Urgent Medical Device Correction letter scheduled to begin on December 17, 2013. ¿x Field service personnel will be notified of the Urgent Medical Device Correction Letter via the Siemens Knowledge Base, as well as information regarding placing labels on the customer system to remind the customer that ///// is not a reportable result. ¿x The Customers were instructed to contact Siemens Healthcare Diagnostics Technical Solution Center if they have technical questions regarding this issue. ¿x Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction.

Device

Device Recall Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems
  • Model / Serial
    ADVIA 1200 with software versions: V2.00 and V2.01  ADVIA 1650 with software versions V3.52 and V4.01
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. USA nationwide and the country of Canada.
  • Product Description
    Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. || Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA