Events

Safety Alert for ADVIA Hematology System Product Name: ADVIA Hematology System Technical Name: Hematology Analyzer ANVISA Registration Number: 10345161959 Hazard Class: II Affected Model: ADVIA 560 Hematology System Affected serial numbers: S020202, S020201, S020200, S020203, S020204, S020206, S020207, S020207, S020210, S020211, S020215

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
    2084
  • Date
    2016-11-21
  • 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 who obtain multiple results for the same sample ID should contact their technical support representative SIEMENS to report the problem. If any of the errors are generated, the result should not be released without checking the database screen in the system, which is displayed following the recommendations of the notification letter. Siemens does not recommend a retroactive review of lab results as a consequence of this problem.
  • Reason
    Siemens detected a potential error, generating multiple results of the same sample id being generated in the database of the advia 560 hematology system, which occurred during the installation of the systems. the database must contain only one record of a sample id number for any date and time. if there are multiple records for the same sample id, it is possible that multiple results can be sent manually or automatically to the interface (lis), printed or displayed on the results report screen.
  • Action
    Field Action Code HI 17-02 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send notification to the client.

Device

ADVIA Hematology System Product Name: ADVIA Hematology System Technical Name: Hematology Analyzer...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; SIEMENS HEALTHCARE DIAGNOSTICS INC
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA