Events

Safety Alert for Combur10Test® UX

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by ROCHE DIAGNOSTIC GMBH || Imported by: PRODUCTOS ROCHE S.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 ID
    IRD-050916
  • Event Number
    INVIMA 2007RD-0000654
  • Date
    2016-09-20
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=121
  • 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 sanitary agency notifies, that roche diagnostics informs that there was an error in the insert for some languages in the sections of limitations, interferences and precision, some test strips of urine, for the test of nitrites (nit), for which erroneously the result is interpreted of some gram-negative bacteria such as gram-positive.

Device

Combur10Test® UX

Manufacturer

ROCHE DIAGNOSTIC GMBH || Imported by: PRODUCTOS ROCHE S.A.