Events

Safety Alert for Advia blood chemistry analyzer

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia 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
    I1402-55
  • Event Number
    INVIMA 2008DM-0002852
  • Date
    2014-02-06
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=210
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    Reports that the system may incorrectly exceed the calibration and quality control (qc) in the following situations: autocalibration with errors related to the.

Device

Advia blood chemistry analyzer
  • Model / Serial
    ADVIA 1200, 1650, 1800 and 2400
  • Product Description
    This equipment is an automated analyzer for blood chemistry tests by colorimetry, enzymatic, endpoint, kinetics, selective ion for continuous random access electrolytes. Uses urine, serum or plasma samples for in vitro diagnostic tests of enzymes, biochemistry, cardiovascular, oncology, anemia, electrolytes, etc. It is an automated system that reports the values of the tests and communicates the clinical results of the patient.
  • Manufacturer
    Siemens Healthcare Diagnostics Inc.

Manufacturer

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