Events

Recall of Device Recall Siemens ADVIA

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
    67027
  • Event Risk Class
    Class 2
  • Event Number
    Z-0940-2014
  • Event Initiated Date
    2013-11-06
  • Event Date Posted
    2014-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124563
  • 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
    Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 - Product Code JJE
  • Reason
    The advia chemistry software systems using certain software versions allows the system to automatically run assay calibrations and quality control (qc).
  • Action
    Siemens sent an Urgent Medical Device Correct letter, dated November 6, 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to retain the recall notification letter with their laboratory records and forward to those who may have received the affected product.

Device

Device Recall Siemens ADVIA
  • Model / Serial
    ADVIA 1200 V2.00 - 10386841 ADVIA 1200 V2.01 - 10469445 ADVIA 1650 V3.52 - 10318424 ADVIA 1650 V4.01 - 10285281 ADVIA 1800 V2.01 - 10639244 ADVIA 2400 V4.01 - 10639265
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution and USA Nationwide.
  • Product Description
    Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 || Product Usage: || The ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 (also known as Clinical Chemistry Systems) are high throughput instruments which perform assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
  • 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