Events

Safety Alert for Ichem Velocity Urine

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by IRIS DIAGNOSTIC DIVISION || Importer: ROCHEM BIOCARE COLOMBIA.

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
    RRD-020216
  • Event Number
    INVIMA 2009RD-0001277
  • Date
    2016-02-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=158
  • 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
    Loose areas of the test strips in several compartments of the analyzer equipment (such as distributors and strip holders), as well as in the compartments of the strips used. this failure can not be detected by the ichem velocity system and, therefore, can lead to erroneous ph results and false negative results in the following tests: nitrites, glucose, blood, bilirubin, urobilinogen, proteins, lauter-acetic acid, ascorbic acid and ketones.

Device

Ichem Velocity Urine

Manufacturer

IRIS DIAGNOSTIC DIVISION || Importer: ROCHEM BIOCARE COLOMBIA