Events

Safety Alert for Cobas analyzer for blood chemistry and immunoassays

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Roche Diagnostics Gmbh || Hitachi High Technologies Corporation || Roche Diagnostics International Ltd. || Roche Diagnostics Graz Gmbh.

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
    I1703-118
  • Event Number
    2011DM-0006900
  • Date
    2017-03-31
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=95
  • 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 identified that there is discrete information regarding the non-standard tubes between the previous version 4.2 and 5.0 of the operator's manual, consisting of incorrect information of the minimum diameter for the non-standard tubes of the referenced modules, which could lead to there are delays in obtaining results of the samples.

Device

Cobas analyzer for blood chemistry and immunoassays

Manufacturer

Roche Diagnostics Gmbh || Hitachi High Technologies Corporation || Roche Diagnostics Internationa...
  • Source
    NIDFSINVIMA