Events

Safety Alert for COBAS 6800/8800 SYSTEMS analyzers

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..

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
    I1609-372
  • Event Number
    2015DM-0013313
  • Date
    2016-09-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=123
  • 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 it has detected that it has detected the possibility of a sample sub-aspiration occurring when the application configuration requests sample volumes below 450μl, caused by foam or bubbles in the sample tube, leading to false presentations. results or results without alarms, generating adverse events on patients.

Device

COBAS 6800/8800 SYSTEMS analyzers
  • Model / Serial
    Cobas 6800, specific serials.
  • Product Description
    The COBAS 6800/8800 SYSTEMS analyzers use an integrated and automated workflow for the analysis of nucleic acids (NAT) based on the polymerase chain reaction (PCR) in order to apply them in diagnostic laboratories and blood tests. The COBAS 6800/8800 SYSTEMS combine the functionalities of instrumentation, consumables, reagents and data management to provide an efficient workflow from sample processing to interpretation of results. This technology applies to any type of NAT test by PCR for health, industry, research, teaching and phytosanitary.
  • Manufacturer
    Roche Diagnostics Gmbh || Roche Diagnostics International Ltd.

Manufacturer

Roche Diagnostics Gmbh || Roche Diagnostics International Ltd.