Events

Safety Alert for ADVIA 1200 Chemistry System; ADVIA 1650 Chemistry System; ADVIA 1800 CHEMISTRY SYSTEM; ADVIA 2400 Chemistry System .. Registro Anvisa: 10345160456; 10345160453; 10345160636; 10345160471, respectively.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnostics Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1341
  • Date
    2001-12-17
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Extra notes in the data
    Siemens Healthcare Diagnostics is conducting corrective field action for the ADVIA 1200, ADVIA 1650, ADVIA 1800 and ADVIA 2400 Chemistry Systems run with software versions V2.00, V2.01; V3.52, V4.01; V2.01; V4.01 respectively. These versions may display AutoCalibration with system-related errors ("s", "t", "S", "r", "F", "A", "M", "Q", or "G"). autocalibration with batch change without error message display and Mid-Calibration Reagent Exchange or Mid-QC generating a calibration curve with a combination of main reagent data and Backup.
  • Reason
    These versions may display autocalibration with system-related errors ("s", "t", "s", "r", "f", "a", "m", "q", or "g").
  • Action
    Corrective field action for ADVIA 1200, ADVIA 1650, ADVIA 1800 and ADVIA 2400 Chemistry Systems run with software versions V2.00, V2.01; V3.52, V4.01; V2.01; V4.01 respectively.

Device

ADVIA 1200 Chemistry System; ADVIA 1650 Chemistry System; ADVIA 1800 CHEMISTRY SYSTEM; ADVIA 2400...

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA