Events

Safety Alert for Name of the product: ADVIA CENTAUR TnI ULTRA /// Record number: 10345160531 /// Affected: 100 tests - lots: 24483099; 28137099; 36527099; 4,251,6099; 46626101; 5,965,5103; 53539104; 72936105; 81676105; 89385106; 94642106. 500 tests - Batches: 24479099; 26294099; 4,320,5101; 46929101; 5,780,5103; 65432103; 52590104; 73322105; 80480105; 86319106; 94250106 / / / Product hazard class: II.

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
    1920
  • Date
    2016-06-28
  • 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
    This problem is not expected to impact the diagnosis or treatment. The ability of the assay to detect the decrease or serial increase of TnI-Ultra will not be impacted; therefore, it is not necessary to review the results of previous tests or to perform repeated tests of the previously reported results.
  • Reason
    Siemens healthcare has forwarded to anvisa the cc 16-12 field action stating that the advia centaur tni ultra product exhibits a greater than 10% change in results from samples with biotin levels greater than 10 ng / ml (41 nmol / l) .
  • Action
    Field Classification: Letter to the Client /// Field action code: CC 16-12 /// Recommendations to users and patients: continue to use the TnI-Ultra ADVIA Centaur assay. Be careful of patients taking biotin supplements that may exhibit a small increase in TnI-Ultra results; however, the ability of the assay to detect the increase or decrease in TnI is maintained.

Device

Name of the product: ADVIA CENTAUR TnI ULTRA /// Record number: 10345160531 /// Affected: 100 tes...

Manufacturer

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