Events

Retiro De Equipo (Recall) de Device Recall Siemens Factor VIII Chromogenic Assay

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
    72752
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0468-2016
  • Fecha de inicio del evento
    2015-11-19
  • Fecha de publicación del evento
    2015-12-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142132
  • 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
    Test, qualitative and quantitative factor deficiency - Product Code GGP
  • Causa
    Factor viii chromogenic assay lot 44637 is showing an increased occurrence of irregular curves when used for measurement on sysmex ca-1500, ca-7000, cs-2000i, cs-2100i, cs-5100 systems. this could lead, under certain circumstances, to an erroneously increased result with a factor viii chromogenic assay.
  • Acción
    Siemens sent an Urgent Medical Device Correction Letter dated November 19, 2015, to all affected customers . The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by Customers: If you are using the affected lot of Factor VIII Chromogenic Assay on a Sysmex CA-1500 or CA-7000 System, please discontinue use. - Due to a different detection principle, the use on BCS and BCS XP is not affected and you can continue using the product on BCS / BCS XP. - Complete and return the Field Correction Effectiveness Check attached to this letter within 30 days. - Review your inventory of this product to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. --- Corrective Action: The Factor VIII Chromogenic Assay Lot Number 44637 kits were placed on product hold on August 19, 2015, at the Siemens Distribution Centers. For further questions, please call ( 914) 524 - 2495.

Device

Device Recall Siemens Factor VIII Chromogenic Assay
  • Modelo / Serial
    Lot Number 44637, exp. 2016-11-30
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution to the state of : Massachusetts and to the countries of : Austria, Czech Republic, France, Germany, Hungary, Italy, Poland, Serbia, Spain and Sweden.
  • Descripción del producto
    Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency
  • 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