Events

Retiro De Equipo (Recall) de BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - CREATININE (ENZYMATIC)

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECKMAN COULTER CANADA L.P..

¿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
    18909
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-12-05
  • 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
    N-acetyl cysteine (nac) when administered in therapeutic concentrations in excess of 500 mg/l (for the treatment of acetaminophen overdose) has been recently determined to interfere with assays for the following analytes: enzymatic creatinine osr6x204 cholesterol osr6x16 uric acid osr6x98 lactate osr6x93 and lipase osr6x30. only these assays are affected. nac is an anti-oxidant and can interfere with assays employing trinder chemical pathways i.E. where hydrogen peroxide (h2o2) is formed and subsequenly reacted with aminoantipyrine and an indicator in the presence of a peroxidase as a catalyst. nac interference has been demonstrated to occur to varying degrees depending on the analyte and therefore not all assays employing trinder chemical pathways are affected. nac interference may lead to falsely low results.

Device

BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - CREATININE (ENZYMATIC)
  • Modelo / Serial
    Model Catalog: OSR61204 (Lot serial: ALL LOTS); Model Catalog: OSR6616 (Lot serial: ALL LOTS); Model Catalog: OSR6116 (Lot serial: ALL LOTS); Model Catalog: OSR6216 (Lot serial: ALL LOTS); Model Catalog: OSR6516 (Lot serial: ALL LOTS); Model Catalog: OSR6698 (Lot serial: ALL LOTS); Model Catalog: OSR6298 (Lot serial: ALL LOTS); Model Catalog: OSR6130 (Lot serial: ALL LOTS); Model Catalog: OSR6198 (Lot serial: ALL LOTS); Model Catalog: OSR6098 (Lot serial: ALL LOTS); Model Catalog: OSR6230 (Lot serial: ALL LOTS); Model Catalog: OSR6193 (Lot serial: ALL LOTS)
  • Descripción del producto
    BECKMAN COULTER AU IMMUNOCHEMISTRY SYSTEM - ENZYMATIC CREATININE
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC