Events

Retiro De Equipo (Recall) de DIMENSION VISTA SYSTEM - HEMOGLOBIN A1C (HBA1C) ASSAY

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS HEALTHCARE LIMITED.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    56973
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-08-19
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    An internal study has show that variance is introduced into the % hba1c result when the sample is run from the small sample container (ssc). previously (vc-14-03) cyclosporine was identified as under-recovering when run from the ssc. capa investigation has found that an unintentional dilution of the sample occurs when whole blood samples are transferred from the ssc to the aliquot well. %hba1c is a ration of two components. with the % hba1c the unintentional dilution of sample introduces variance into the final %hba1c result.

Device

DIMENSION VISTA SYSTEM - HEMOGLOBIN A1C (HBA1C) ASSAY
  • Modelo / Serial
    Model Catalog: K3105A (Lot serial: 14041BA); Model Catalog: 10470481 (Lot serial: 14132BA); Model Catalog: K3105A (Lot serial: 14132BA); Model Catalog: 10470481 (Lot serial: 14041BA); Model Catalog: 10470481 (Lot serial: 13273BA); Model Catalog: K3105A (Lot serial: 13273BA); Model Catalog: 10470481 (Lot serial: 13294BA); Model Catalog: K3105A (Lot serial: 13294BA); Model Catalog: 10470481 (Lot serial: 13308BA); Model Catalog: K3105A (Lot serial: 13308BA); Model Catalog: 10470481 (Lot serial: 13329AA); Model Catalog: K3105A (Lot serial: 13329AA); Model Catalog: 10470481 (Lot serial: 13350AA); Model Catalog: K3105A (Lot serial: 13350AA); Model Catalog: K3105A (Lot serial: 14006AA); Model Catalog: 10470481 (Lot serial: 14006AA)
  • Descripción del producto
    Dimension Vista System-Hemoglobin A1C (HBA1C) A
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC