Events

Safety Alert for Product name: cobas® MPX Technical name: HIV, HBV AND HCV VIRUS NUCLEIC ACID ANVISA registration number: 10287411182 Hazard class: IV Affected model: 96 tests Serial numbers affected: 191957/195775

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Roche Diagnóstica Brasil Ltda; Roche Diagnostics 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
    2313
  • Date
    2017-06-14
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    The INCQS was duly informed on this matter in case of need of action. There are no users / patients affected by this issue.
  • Reason
    Under specific conditions, there is a possibility that target-specific results sent to a customer's lis will not match the results displayed in the cobas® 6800/8800 systems user interface (ui). this applies to cobas® 6800/8800 systems software versions 01.01.09, 01.01.10 and 01.02.12. note: this action does not impact local users in brazil because it was not marketed in the country.
  • Action
    Field Action Code SBN-RMD-2017-002 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will send informative.

Device

Product name: cobas® MPX Technical name: HIV, HBV AND HCV VIRUS NUCLEIC ACID ANVISA registration ...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH