Events

Safety Alert for urine analyzer

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by N/A.

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 Number
    2014DM-0011237 ; 2014DM-0011773
  • Date
    2018-02-07
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=56
  • 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

urine analyzer
  • Model / Serial
    u601 and u701, specific serials.
  • Product Description
    The urine analyzer cobas u 601 (called the urine analyzer in a generic way) is a fully automated urinalysis system designed for the qualitative quantitative in vitro quantitative determination of urinary analytes, such as PH, leukocytes, nitrites, proteins, glucose, ketones, urobilinogen, bilirubin yerithrocytes, as well as specific density, color and turbidity. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders. This system is intended to be used by qualified operators in clinical laboratories. The analyzer can process up to 240 samples per hour. It is automated.The team cobas u 701 MICROSCOPY ANALYZER (denominadomicroscopio analyzer) is an orinatotalmente automated microscopy system designed for the quantitative invitro determination of erythrocytes and leukocytes, for the semiquantitative determination of squamous and non-squamous epithelial cells, bacteria and cylindershyaline and for the qualitative determination of pathological cylinders, crystals, yeast, mucus and sperm in the urine. The instrument consists of a microscopy system which increases the urinary sediment of the patients sample and presents them on an LCD screen for reading and review by the laboratory professional. These measurements are useful in the evaluation of renal, urinary, hepatic and metabolic disorders. This system is intended to be used by operators qualified in clinical laboratories.
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    NIDFSINVIMA