Events

Retiro De Equipo (Recall) de ABL90 FLEX Analyzer Radiometer Medical ApS

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
    66875
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0816-2014
  • Fecha de inicio del evento
    2013-10-15
  • Fecha de publicación del evento
    2014-01-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123921
  • 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
    Electrode, ion specific, sodium - Product Code JGS
  • Causa
    Radiometer become aware that if the abl90 flex is tilted, this may potentially cause a negative bias on sodium (na+) results.
  • Acción
    Radiometer sent an Urgent Medical Device Recall letter dated November 5, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check all of their ABL90 FLEX analyzers and ensure that the analyzer is placed on a horizontal platform/table. If the analyzer is placed on a roll stand, please ensure that the support plate is aligned horizontally and locked in this position. Customers were asked to complete and fax the accompanying acknowledgment form in order to confirm their receipt of this field safety notice. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, option 4. For questions regarding this recall call 440-871-8900.

Device

ABL90 FLEX Analyzer Radiometer Medical ApS
  • Modelo / Serial
    Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey & United Kingdom.
  • Descripción del producto
    ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 || Br¿nsh¿j, Denmark || A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Dirección del fabricante
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA