Events

Retiro De Equipo (Recall) de Device Recall ABL 700 series analyzers

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Radiometer America Inc.

¿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
    36812
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1094-2007
  • Fecha de inicio del evento
    2006-11-13
  • Fecha de publicación del evento
    2007-07-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49392
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    blood gas analyzers - Product Code CHL
  • Causa
    Software anomaly. protein removing program incorporated in the operating software for versions: v3.833 and v5.24, of the abl700 and abl800 blood gas analyzers, may allow for protein build up on the electrode membranes of blood gas analyzers. this condition can influence analyzer results. when the protein removal program is run too frequently, more than once a week, or when running the protein rem.
  • Acción
    The firm issued a 'Safety Alert Notice' [FAN 915-248] to all customers which received the recalled ABL700 and ABL800 Analyzers equipped with the referenced software. The 11/13/2006 notice describes the problem concerning the Protein Removal program to the user/customers and emphasizes that the frequency of running the program in these software versions must be no more than once a week in order to prevent the protein build-up problem. It also contains additional recommendations for the user/customers for operation of these analyzer and informs the customers that a Radiometer Service Rep. will be coming out and making a software upgrade to these systems within the next few weeks. The alert notification is accompanied by a 'FAX FORM' to be signed and completed by each customer in order to verify that the alert notification has been received and that the staff members responsible for operating and maintaining the analyzer(s) on-site have been informed of this situation and that the necessary changes in the Operator's Manual concerning the Cleaning, Protein Removal, and Decontamination programs have been made.

Device

Device Recall ABL 700 series analyzers
  • Modelo / Serial
    All serial numbers of the ABL 700 series containing software version 3.833.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The recalled analyzers were distributed to customers nationwide throughout the U.S. and in some parts of Canada.
  • Descripción del producto
    ABL 700 Series blood gas analyzers equipped with Software Version 3.833.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Dirección del fabricante
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1598
  • Source
    USFDA