Events

Safety Alert for Trade name: Dimension Amonia Flex Technical name: AMÔNIA Registration number ANVISA: 10345161934 Hazard class: II Affected model: 120 tests Serial numbers affected: FB7152; BA7250

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
    2074
  • Date
    2017-01-12
  • 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 the discontinuation and disposal of the batches mentioned and subsequent replacement request. The company does not recommend retrospective analysis of previously reported results.
  • Reason
    Siemens healthcare diagnostics has determined that the dimension fb7152, eb7180, ba7194, ea7223, and ba7250 ammonia (amm) reagent lots are not maintaining the required 60 day calibration interval due to reagent instability and may also display the abnormal assay message in the results. these batches may show precise changes in results obtained for both patients and quality controls, leading to more frequent recalibrations than the 60-day period indicated in the instructions for use (ifu) of this reagent.
  • Action
    Field Action DC Code 17-01 released under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

Trade name: Dimension Amonia Flex Technical name: AMÔNIA Registration number ANVISA: 10345161934 ...

Manufacturer

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