Events

Safety Alert for ADVIA CENTRALINK Technical Name: Software ANVISA Registration Number: 10345161928 Hazard Class: I Affected Model: ADVIA CentraLink Affected serial numbers: DC1733486, DC1740245, DC1689706, 5699N3J, JYKZN3J, 66MDN3J, GBY382J, DC1751283, DC1793356, DC18449841, DC1846667, DC1892717, DC1906259, DC1921198, DC1921200, DC1916941, DC1948495, DC1950630, DC1703782

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
    2078
  • Date
    2016-12-16
  • 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
    Siemens recommends that the LIS specify the type of sample in the work order. CentraLink software is designed to operate in an environment in which information pertaining to the type of sample is specified in the order that is received from the LIS. The CentraLink configuration will be reviewed. If the LIS does not include information regarding the type of sample in the sample order sent to CentraLink and pre-tests checked against the sample type, the settings will be updated. Siemens does not recommend retroactive analysis of previously generated results.
  • Reason
    Siemens healthcare diagnostics has determined that there is a remote possibility for centralink to send an order to the advia automation system without specifying the type of sample. this event may occur when an order is received from the lis without the sample type information, requiring that such sample type information be placed in centralink based on the type of test sample in the order.
  • Action
    Field Action Code ISW 17-01 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Notification to the client.

Device

ADVIA CENTRALINK Technical Name: Software ANVISA Registration Number: 10345161928 Hazard Class: I...

Manufacturer

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