Events

Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1920
  • Date
    2016-06-28
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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.
  • Cause
    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.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA