Events

Retiro De Equipo (Recall) de Device Recall Urea Nitrogen (UN) Reagent Kit

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 Siemens Healthcare Diagnostics, 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
    79932
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2062-2018
  • Fecha de inicio del evento
    2018-03-27
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163963
  • 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
    Urease and glutamic dehydrogenase, urea nitrogen - Product Code CDQ
  • Causa
    Urea nitrogen reagent kit demonstrated an increased incidence of calibration failures. results cannot be generated by the system when calibration fails.
  • Acción
    Date recall was initiated: 03-27-18 Customer communication was sent on 04-03-18 Urgent Medical Device Recall (CHC18-04.A.US) was distributed to all customers in the United States and an Urgent Field Safety Notice (CHC18-04.A.OUS) was distributed to all customers outside the United States who have received ADVIA Chemistry Urea Nitrogen reagent kit lots 408143 and 418290 (Lot 418290 was not sold in the US). These letters instruct the customers to discontinue use of reagent kit lots 408143 and 418290 and to contact their Customer Care Center for replacements kits. In the US the method of distribution is Fed Ex and outside the US the distribution is determined at the country level.

Device

Device Recall Urea Nitrogen (UN) Reagent Kit
  • Modelo / Serial
    Lot # Expiry UDI# 408143 2018-06-28 00630414517513 418290 2018-06 - 28 00630414517513
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and worldwide
  • Descripción del producto
    ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Dirección del fabricante
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA