Events

Retiro De Equipo (Recall) de ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - INSTRUMENT W/ISE MODULE

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
    84479
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-04-03
  • 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
    As per the manufacturer during a complaint investigation it was determined that the abx pentra 400 does not provide a low or high out of linearity range flag for ise results (i.E. sodium chloride and potassium). the only flag that is present in these situations is the ref-range_low or _high analysis flags and an "l" or "h" flag on the patient report. there was no alarm informing the user that the value was outside of the instrument's linearity limits. the lack of an out of linearity range flag without any indication that the results may actually be invalid due to the linearity limits being exceeded. this is a software design oversight for the abx pentra 400 i.S.E. module instruments.

Device

ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - INSTRUMENT W/ISE MODULE
  • Modelo / Serial
    Model Catalog: P4000000NUA1 (Lot serial: all serial)
  • Descripción del producto
    ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM
  • Manufacturer
    FISHER SCIENTIFIC

Manufacturer

FISHER SCIENTIFIC