Events

Alerta De Seguridad para Cal Calibrator A Advia Centaur, ACS: 180 Systems, Kit containing: 2 vials (5.0 mL / vial) of high calibrator; 2 vials (5.0 mL / vial) of low calibrator. Kit containing: 6 vials (5.0 mL / vial) of high gauge; 6 vials (5.0 mL / vial) of low calibrator //// Registration: 10345160165, hazard class II. Affected lots: 40978A84; 41239A84; 41846A84; 44162A84; 47938A84; 51961A86; 53232A86; 55812A86; 95551A87; 07628A87; 18026A87.

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
    1720
  • Fecha
    2015-10-28
  • 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
    Siemes Healthcare identified that these observed differences would not affect patient diagnosis or monitoring, although failures in 1: 4 and 1: 8 dilution recoveries with Calibrator A could affect T4 accuracy levels above the assay range .
  • Causa
    Siemens healthcare diagnostics proactively conducted a customer notification regarding 1: 4 and 1: 8 manual dilution recovery in the advia centaur t4 assay, used in the advia centaur xp, advia centaur xp, advia centaur xp and advia centaur cp systems. siemens has identified that recovery percentages for dilutions of patient samples 1: 4 (with calibrator a prior to the batches terminated at 84 and 86) and 1: 8 (batches terminated at 84, 86 and 87) are lower than the advia centaur t4 instruction for use. (see attached).
  • Acción
    Correction of Instructions for Use The company will: discontinue the use of 1: 8 manual sample dilutions of T4 samples on ADVIA Centaur systems. /// Manual dilutions 1: 2 and 1: 4 can be performed for T4 samples with results above the assay range for Batches of Calibrator A terminated at 87 and above. It was confirmed that these dilutions performed as expected. /// Batches of Calibrator A terminated at 84 and 86 may continue to be used for all other assays requiring Calibrator A, except for dilutions of T4 samples. (SEE ANNEX) .Code of Action: CN CC 15-14.

Device

Cal Calibrator A Advia Centaur, ACS: 180 Systems, Kit containing: 2 vials (5.0 mL / vial) of high...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc.
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA