Events

Alerte De Sécurité sur ADVIA Centaur HIV Ag / Ab Combo Assay (CHIV), registration 10345161863, risk class IV, Lots: 73544070; 75980070; 76675070; 78024070; 79139070.

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
    1760
  • Date
    2015-11-26
  • 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
    The record holder reports that calibration failures or QC results outside the range may lead to a time delay of the result for the CHIV.
  • Cause
    Calibrations failures of the hiv ag / ac combo (chiv) assay of advia centaur systems (lots of kits mentioned in portuguese letter cn cc 15-27) due to inaccuracy in the low calibrator. an invalid calibration status prevents chiv results from being reported. siemens confirmed that due to a sporadic increase in relative light units (rlus), inaccuracy was observed with the low calibrator, negative qc material or negative samples, however, the clinical usefulness of the assay was not affected.
  • Action
    The company that owns the registry does a complement of the instruction of use and clarifies that the clients can continue using the tests, therefore the clinical utility of the same one is not affected. In this case, two guidelines are given: If a valid calibration is not obtained, contact your local or company representative for technical assistance and reagent replacement. If a valid calibration has been processed with the CHIV kit lots described in this form and the quality control results are within the range, reporting of patient outcomes can be performed. //// Field action code: CN CC 15-27.

Device

ADVIA Centaur HIV Ag / Ab Combo Assay (CHIV), registration 10345161863, risk class IV, Lots: 7354...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA