Events

Safety Alert for Immunoassay 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. || Siemens Healthcare Diagnostics Manufacturing Ltd.

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
    I1806-393
  • Event Number
    2015DM-0013041
  • Date
    2018-06-18
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=42
  • 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

Device

Immunoassay Analyzer
  • Model / Serial
    CENTAUR XPT, software version 1.3
  • Product Description
    The ADVIA CENTAUR XPT SYSTEM is an automated analyzer instrument for direct chemi-luminescence continuous random access immunoassay testing. Uses urine samples, oplasm serum for in vitro diagnostic tests (IVD) of the test groups include those of fertility, thyroid function, oncology, cardiovascular, anemia, determination of therapeutic drugs, infectious diseases, allergy, adrenal and metabolic function. It is an automated system that reports the values of the tests and reports results of the patient's clinics. XPT system is high efficiency and performance for specialized tests and routine in the clinical laboratory.
  • Manufacturer
    Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagnostics Manufacturing Ltd

Manufacturer

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