Events

Retiro De Equipo (Recall) de ADVIA CHEMISTRY SYSTEM - OPIATE (OP_2) 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
    53297
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-08-19
  • 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
    Siemens investigation confirmed that the introduction of a new syva polyclonal antibody lot (g1) for use in the dimension urine opiates screen has resulted in an alteration of specificity for levallorphan levorphanol nalorphine and oxycodone at the 300 and 2000 ng/ml cutoff concentration. as a result in the change in sensitivity to the cross reactant the claims for these compounds are no longer accurate for either the 300 or 2000 ng/ml cutoff as stated within the instructions for use (ifu). further investigation confirmed that syva beckman coulter and advia chemistry opiate reagents are impacted as well due to a common raw material used in the assays.

Device

ADVIA CHEMISTRY SYSTEM - OPIATE (OP_2) ASSAY
  • Modelo / Serial
    Model Catalog: 10378763 (Lot serial: 290); Model Catalog: 10378763 (Lot serial: 310); Model Catalog: 10378763 (Lot serial: 320); Model Catalog: 10378763 (Lot serial: 330); Model Catalog: 10378763 (Lot serial: 340)
  • Descripción del producto
    ADVIA CHEMISTRY OPIATE (OP_2) ASSAY;ADVIA 1200 CHEMISTRY SYSTEM- OPIATE (OP_2) ASSAY2
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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