Events

Retiro De Equipo (Recall) de Device Recall HEMOCHRON(R) HEPARIN RESPONSE TEST

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 International Technidyne Corp..

¿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
    56114
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2110-2010
  • Fecha de inicio del evento
    2010-06-24
  • Fecha de publicación del evento
    2010-07-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92693
  • 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
    assay, heparin - Product Code KFF
  • Causa
    An ingredient in the rqchrt whole blood controls for use with hemochron kaolin and celite hrt test tubes may become less potent over time and result in excessive high lqc failures.
  • Acción
    ITC sent "URGENT MEDICAL DEVICE RECALL" letters dated June 24, 2010, via Federal Express to Laboratory Director, Clinical Laboratory Manager, or Point of Care Coordinator consignees/customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to check their inventory for the product, if they have boxes or loose vials to please stop using the product, remove it from inventory and contact ITC Technical Support to arrange return. They were also instructed to complete the attached Customer Account Tracking Form, whether or not they have remaining inventory, and return it by fax, email or mail. If you have any questions, please call ITC Technical Support at 800-631-5945 (US) or 732-548-5700 (international), Extension 4707 or email techsupport@itcmed.com.

Device

Device Recall HEMOCHRON(R) HEPARIN RESPONSE TEST
  • Modelo / Serial
    Test kit lot numbers: H9KHR002, Exp 05/2010 and BOKHR001, Exp 08/2010; RAF 10-016
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including states of CA, NC, TX, FL, MD, OK, NY, and NJ and country of Italy.
  • Descripción del producto
    RQCHRT HRT Control Level 1 & 2; || Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test Tubes. || 20 vials Whole Blood - 2.0mL; dried || 20 vials Diluent - 4.0 mL || The Hemochron HRT Whole Blood Quality Controls are intended to be used to perform quality control assays using the Hemochron HRT test tubes.
  • Manufacturer
    International Technidyne Corp.

Manufacturer

International Technidyne Corp.
  • Dirección del fabricante
    International Technidyne Corp., 6-8 Olsen Avenue, Edison NJ 08820-2419
  • Empresa matriz del fabricante (2017)
    Werfenlife Sa.
  • Source
    USFDA