Events

Retiro De Equipo (Recall) de ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - MULTICALIBRATORS

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

¿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
    22018
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-10-06
  • 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
    This recall has been initiated due to the potential that it was observed that creatinine rate blank method calibrator and control results were reporting values lower than target values indicated in the associated abx pentra multical n control and p control annexes. horiba has reassigned the target values and updated annexes for the products and lot numbers.

Device

ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - MULTICALIBRATORS
  • Modelo / Serial
    Model Catalog: A11A01652 (Lot serial: 1204103); Model Catalog: A11A01652 (Lot serial: 1304901); Model Catalog: A11A01652 (Lot serial: 1304902); Model Catalog: A11A01653 (Lot serial: 1300602); Model Catalog: A11A01654 (Lot serial: 1300602); Model Catalog: A11A01654 (Lot serial: 1300802); Model Catalog: A11A01654 (Lot serial: 1300803); Model Catalog: A11A01653 (Lot serial: 1300802); Model Catalog: A11A01653 (Lot serial: 1300803)
  • Descripción del producto
    ABX Pentra 400 Clinical Chemistry System - MultiCal
  • Manufacturer
    FISHER SCIENTIFIC

Manufacturer

FISHER SCIENTIFIC