Events

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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1760
  • Fecha
    2015-11-26
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    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.
  • Acción
    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.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA