Events

Safety Alert for Commercial name: cobas c 501 module and cobas c 502 module. Technical name: Physiological Fluid Analyzer. ANVISA registration number: 10287410597 and 10287410878. Risk class: I and II. Affected Model:. Serial numbers affected: 4745914001, 5964067001

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
    2360
  • Date
    2017-08-10
  • 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
    Customers and users are advised not to over-tighten the bolts when reinstalling the cover after maintenance. When removing screws for maintenance, avoid touching the edge of the USM Cover. If you want to notify technical complaints and adverse events use the following channels: Notivisa: Adverse Event (AE) and Technical Complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    Roche diagnostics gmbh, a legal product manufacturer, informs its customers and users of the c501 and c502 modules that an operator was injured during a maintenance task by removing the cover of the ultrasonic homogenizer (usm cover 3) from a cobas c 502 module whereas cobas c 501 and cobas c 502 modules share the same hardware, roche diagnostics gmbh, manufacturer of the product, decided to inform and require operators of both systems to carry out the maintenance task with special care in order to avoid the occurrence of accidents.
  • Action
    Field Action Code SBN-CPS-2017-015 triggered under the responsibility of the company Roche Diagnóstica Brasil Ltda. Software Update.

Device

Commercial name: cobas c 501 module and cobas c 502 module. Technical name: Physiological Fluid A...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH