Events

Safety Alert for Commercial name: cobas and 602 module - cobas 8000 Technical name: Physiological Fluid Analyzer ANVISA registration number: 10287410878 Hazard class: II

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
    2233
  • Date
    2017-03-17
  • 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
    Ensure that only pipes with a diameter of 13 to 16 mm are used in the cobas and 602 module. Replace any cobas® 8000 operator manual from version 5.0 with the new version 5.1, which states the correct non-standard pipe specifications. #### 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
    We would like to inform you that roche diagnostics gmbh, manufacturer of cobas® 8000 abroad, found a discrepancy between versions 4.2.1 and 5.0 of the cobas® 8000 operator's manual for non-standard tubes (tnps). version 5.0 of the operator's manual misleadingly indicates that tnps of 11 to 16 mm in diameter can be used in the cobas and 602 modules. however, only tnps with diameters of 13 to 16 mm are allowed for this module.
  • Action
    Field Action Code SBN-CPS-2017-002 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Company will update, correct or supplement the instructions for use.

Device

Commercial name: cobas and 602 module - cobas 8000 Technical name: Physiological Fluid Analyzer A...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH