Events

Safety Alert for COBAS HIV-1 and COBAS HBV

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. || 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-020217.
  • Event Number
    INVIMA 2015RD-0003312, INVIMA 2016RD-0003830, ; INVIMA 2012RD-0000566-R1.
  • Date
    2017-02-28
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=99
  • 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 healthcare agency notifies that the hiv-1 and hbv tests, which are carried out in the cobas 4800 system, can generate false negative results, for samples that exceed the limit of quantification of the test, that is to say that they contain a high viral load.

Device

COBAS HIV-1 and COBAS HBV

Manufacturer

ROCHE DIAGNOSTICS GmbH. || Imported by: PRODUCTOS ROCHE S.A.