Events

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

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
    45862
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-12-10
  • 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
    During a complaint investigation at the manufacturer (horiba abx sas) a shift in the target value of the abx pentra n control was detected for potassium-e values related to the abx pentra 400 only. clinical laboratories will observe the potassium n control result will be reported in the lower range of the n control target range. the original target value annex shipped with the abx pentra n control lot#: 1300801 identified the potassium target value as 4.00 mmol/l with a target range of 3.70 -4.30 mmol/l (equivalent to 15.6 mg/dl with a target range of 14.4 -16.8 mg/dl). horiba abx sas (the manufacturer) has reassigned the target value and range a nd updated the annex for this lot number to reflect a target value of 3.76 mmol/land a target range of 3.46 - 4.06 mmol/l (equivalent to 14.7 mg/dl with a target range of 13.5 - 15-.9 mg/dl) for potassium. this issue is only applicable to potassium-e values reported on the abx pentra 400 chemistry analyzer with the ise module only. no other analyzers or other analyte values are affected.

Device

ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - CONTROLS
  • Modelo / Serial
    Model Catalog: A11A01653 (Lot serial: 1300801)
  • Descripción del producto
    ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - CONTROLS
  • Manufacturer
    FISHER SCIENTIFIC

Manufacturer

FISHER SCIENTIFIC