Events

Retiro De Equipo (Recall) de Device Recall ABL800 Series analyzer with FLEXQ module

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
    37167
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0705-2007
  • Fecha de inicio del evento
    2007-01-16
  • Fecha de publicación del evento
    2007-04-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50031
  • 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
    Analyzer; Blood gases - Product Code CHL
  • Causa
    In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. this occurs when a safe pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode.
  • Acción
    Radiometer America issued a recall letter to their U.S. customers dated 1/16/2007. The letter informs the customers of this software anomaly and the conditions underwhich analyzer results can be stored with incorrect Patient Demographics. The letter goes on to inform the customers that a Radiometer Service Representative will be visiting each customer location shortly in order to upgrade the affected software. In the meantime, the letter recommends that the customer(s) not pre-register their samples. The letter is accompanied by an attached FAX FORM which the customer is asked to sign and complete in order to verify receipt of the recall letter and to fax back to the recalling firm.

Device

Device Recall ABL800 Series analyzer with FLEXQ module
  • Modelo / Serial
    There are no specific lot codes. (devices equipped with software version 5.2 to 5.27)
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA including states of NY, KS, SD, OH, TX, KY, NC, IL, MO, AL, UT, CO, CA, NM, and MI and Country of Denmark
  • Descripción del producto
    ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27
  • Manufacturer
    Radiometer America Inc

Manufacturer

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