Events

Safety Alert for ADVIA Centaur BR Technical Name: ANTIGEN CA ANVISA Registration Number: 10345161849 Hazard Class: III Affected Model: 250 Test Kit / 50 Test Kit

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
    2269
  • Date
    2017-04-13
  • 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 discontinuing dilution of samples using ADVIA Centaur BR (CA 27.29) with Multi-Diluent 1 batches terminated at 2577 and future batches of Multi-Diluent 1 until further notice. The company does not recommend a review of the results previously generated.
  • Reason
    Siemens healthcare diagnostics has confirmed that the advia centaur br (ca 27.29) test does not linearly dilute when used with multi-diluent 1 batches 1 terminated at 2577 and to all future batches until a further notification. when diluted, some samples have a recovery greater than 120% from the expected pure value. the root cause of this problem is currently under investigation.
  • Action
    Field Action Code CC 17-12 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

ADVIA Centaur BR Technical Name: ANTIGEN CA ANVISA Registration Number: 10345161849 Hazard Class:...

Manufacturer

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