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 || 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
    I1609-405
  • Event Number
    2009DM-0003229
  • Date
    2016-09-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=120
  • 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 he has detected the possibility of obtaining erroneous results due to a conflict in the measurement time, obtaining the following error message "7002: a software error 108000572 has occurred", leading to delays in the analysis of the samples and possible adverse events on patients.

Device

Cobas analyzer for blood chemistry and immunoassays
  • Model / Serial
    COBAS C-111 SERIES, with software versions 3.0.3, 4.1.0 and 4.2.0
  • Product Description
    This equipment is a continuous analyzer of random access and controlled by its software for the photometric analysis and deimmunoassays of multiple blood chemistry, immunology and electrolyte tests for low volumes of samples. It also uses the selective electrolyte ion module.
  • Manufacturer
    Roche Diagnostics Gmbh || Roche Diagnostics International Ltd || Roche Diagnostics Graz Gmbh

Manufacturer

Roche Diagnostics Gmbh || Roche Diagnostics International Ltd || Roche Diagnostics Graz Gmbh