Events

Safety Alert for ADVIA CHEMISTRY XPT SYSTEM

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Jeol Ltd. || 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
    I1608-319
  • Event Number
    2015DM-0013005
  • Date
    2016-08-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=128
  • 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
    The manufacturer reports that it has detected the possibility of a software error that may alter the result obtained by the analyzer for the calculation of hemoglobin, leading to possible adverse events on the patients.

Device

ADVIA CHEMISTRY XPT SYSTEM
  • Model / Serial
  • Product Description
    The ADVIA CHEMISTRY XPT SYSTEM instrument is an automated analyzer for clinical chemistry or blood chemistry tests that processes tests in serum, plasma, urine or cerebrospinal fluid in random access mode and by series with a production rate of 1800 pho- totometric tests per hour and 600 tests of electrolytes (ISE) by now. Performs colorimetry, enzymatic, puntofinal, kinetic, selective ion for electrolytes. Of continuous random access. Uses urine, serum or plasma samples for in vitro diagnostic tests (IVD) of enzymes, biochemistry, cardiovascular, oncology, anemia, electrolytes, etc. It is in automated system that reports the values of the tests and communicates the results of clinical of the patient.
  • Manufacturer
    Jeol Ltd. || Siemens Healthcare Diagnostics Inc.

Manufacturer

Jeol Ltd. || Siemens Healthcare Diagnostics Inc.
  • Source
    NIDFSINVIMA