Events

Safety Alert for Clinitek uroanalysis analyzer

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Siemens Health Care Diagnostics Inc || Siemens Health Care Diagnostics Manufacturing Limited.

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
    I1508-355
  • Event Number
    2014DM-0011303
  • Date
    2015-08-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=174
  • 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 states that it has identified a potential error in the reports obtained with the referenced analyzer, if the clarity report adjustment is disabled, leading to potential failures in the analysis of samples and subsequent diagnosis.

Device

Clinitek uroanalysis analyzer
  • Model / Serial
    NOVUS WITH RACK, serial S001046, S001259, S001294, S001295, S001308, S001331, S001333, S001524, S001555, || S001311, S001312, S001313, S001328, S001520, S001550, || S001553 and S001569
  • Product Description
    The CLINITEK NOVUS ™ automatic urine chemical analyzer is a fully automated urine analyzer. It is designed for professional use in vitro diagnosis. The CLINITEK NOVUS analyzer is designed to read only SIEMENSHEALTHCARE DIAGNOSTICS CLINITEK NOVUS cassettes. Elanalizer is designed to measure the following components of urine: albumin, bilirubin, blood (occult), creatinine, glucose, ketone (acetoacetic acid), leukocytes, nitrite, ph, proteins, urobilinogen, density (specific gravity), albumin-creatinine ratio and protein-creatinine ratio. These measures are used to help make the diagnosis in the following areas: carbohydrate metabolism (such as diabetes mellitus), kidney function, liver function, metabolic disorders, urinary tract infections the analyzer reports the color and appearance of the sample. The automatic urine analyzerCLINITEK NOVUS is designed for centralized laboratories.
  • Manufacturer
    Siemens Health Care Diagnostics Inc || Siemens Health Care Diagnostics Manufacturing Limited

Manufacturer

Siemens Health Care Diagnostics Inc || Siemens Health Care Diagnostics Manufacturing Limited
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA