Events

Safety Alert for Cobas® HIV-1 and HBV Technical Name: ANVISA Registration Number: Hazard Class: IV Model Affected: Registries: 10287411153 and 10287411154 Serial Numbers Affected: 1) cobas® HIV-1 Test (6979599190) Lot W11636 2 ) cobas® HBV Test (6979564190) Lot W14007

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
    2224
  • Date
    2017-02-22
  • 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 has been duly informed on this issue in case there is a need for action. There are no users / patients affected by this issue. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Reason
    Roche diagnostica brasil has received from its overseas manufacturer (roche diagnostics gmbh) a statement regarding the results of the cobas® hiv-1 and cobas® hbv tests used in the cobas 4800 system and, therefore, shares the information only for information, since brazil did not import these batches for use in clinical laboratories. the tests were all used for analysis and validation in incqs (national institute of health quality control) and there is no risk of release of results for patients. field action title: potential false negative result with the cobas® hiv-1 and cobas® hbv tests for use in the cobas 4800 system.
  • Action
    Field Action Code SBN-RMD-2016-024 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will make information.

Device

Cobas® HIV-1 and HBV Technical Name: ANVISA Registration Number: Hazard Class: IV Model Affected:...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH