Events

Safety Alert for Registration number: ADVIA Centaur Systems //// Registration ANVISA: 10345161944. Risk class I //// model: ADVIA Centaur XPT /// Serial Numbers: IRL07221522; IRL08401537; IRL09721551; IRL09741551; IRL09801552; IRL10151604

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Inc..

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
    1927
  • Date
    2016-06-24
  • 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
    If you have any questions regarding this field action, please contact: E-mail temas.regulatorios.br@siemens.com Internet www.siemens.com Telephone 0800 129 633 Fax (11) 3908-3995
  • Reason
    The manufacturer has identified problems related to: sample tip error, daily maintenance, release of sample results below / above linearity, auto-repeat conditions processing of results it is possible that a sample tip error or a failure to complete the daily cleaning procedure, which could lead to discrepant results for patient samples and quality controls. according to the registrant of this product, the likelihood of these faults occurring is extremely unlikely (siemens points out that failure to complete the daily cleaning procedure may occur if fluid systems are not filled in prior to commencing the daily procedure). for the other problems described in the portuguese charter there is a potential for delay in releasing the result.
  • Action
    Action code CSW 16-04. Letter Sending, prepared in May / 2016, to Customers.

Device

Registration number: ADVIA Centaur Systems //// Registration ANVISA: 10345161944. Risk class I //...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA