Events

Retiro De Equipo (Recall) de ADVIA CHEMISTRY SYSTEM - CHEMISTRY CALIBRATORS

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
    41193
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-09-27
  • 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
    Quality control (qc) is shifting higher impacting direct bilirubin (dbil_2) with siemens chemistry calibrator lots 090445b and 090445c from previous lots 090445 and 090445a. observed qc shifts are ~7-9% higher with calibrator lots 090445b and 090445c. an urgent field safety notice has been issued by the manufacturer to provide affected customers with reassigned system specific values for the dbil_2 ssvs for chemistry calibrator lot numbers 090445b and 090445c. manufacturer has determined that the dbil_2 ssvs currently assigned to these lots may cause an average shift of +7-9% in quality control and sample recovery at a level of 3 mg/dl. the urgent field safety notice provides reassigned values for the dbil_2 ssvs for chemistry calibrator lot numbers 090445b and 090445c.

Device

ADVIA CHEMISTRY SYSTEM - CHEMISTRY CALIBRATORS
  • Modelo / Serial
    Model Catalog: T03-1291-62 (Lot serial: 090445C); Model Catalog: 09784096 (Lot serial: 090445C); Model Catalog: 10312279 (Lot serial: 090445C); Model Catalog: T03-1291-62 (Lot serial: 090445B); Model Catalog: 09784096 (Lot serial: 090445B); Model Catalog: 10312279 (Lot serial: 090445B)
  • Descripción del producto
    ADVIA CHEMISTRY SYSTEM - CHEMISTRY CALIBRATORS
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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