Events

Retiro De Equipo (Recall) de Device Recall Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT)

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
    57405
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1093-2011
  • Fecha de inicio del evento
    2010-11-30
  • Fecha de publicación del evento
    2011-02-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96055
  • 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
    Coagulation Instrument - Product Code KQG
  • Causa
    Some activated clotting time (act) tubes may contain a component that does not meet its specification, making it possible for a failure to detect a tube or the presence of a clot.
  • Acción
    ITC notified their distributors and end user customers with an Urgent Medical Device Recall letter dated November 29, 2010 through UPS overnight mail. The letter identified the affected product and explained the reason for the recall. Distributors and customers should check their inventory for any affected product. Distributors should immediately discontinue shipment of the affected product and place the product on hold. Then regardless of whether they have any remaining inventory, they should complete the enclosed Distributor Account Tracking Form. The firm will contact them to arrange for any affected product to be returned and will credit them for any unused, returned product. Customers are to stop using the affected product and remove it from their inventory. They should also complete the attached Customer Account Tracking Form and return it to the firm. The firm will contact them to arrange for the return of any affected inventory and will credit the customers for any unused, returned product. If customers believe that they have experienced a problem with the product, they should take any additional actions regarding their records or patients. Questions should be directed to ITC Nexus Dx Technical Support at 800-631-5945 (US) or 732-548-5700 (International) or e-mail techsupport@itcmed.com.

Device

Device Recall Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT)
  • Modelo / Serial
    Lot Number G0FTE157A, Expiration Date 7/31/2013 Lot Number G0FTE158A, Expiration Date 7/31/2013 Lot Number G0FTE159A, Expiration Date 7/31/2013 Lot Number G0FTE159B, Expiration Date 7/31/2013
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date are listed. Each box contains 95 ACT tubes tests. || Used for heparin anticoagulation monitoring during cardiopulmonary bypass surgery, percutaneous transluminal coronary angioplasty (PTCA), interventional radiology, extracorporeal membrane oxygenation (ECMO), hemofiltration, hemodialysis and critical care.
  • 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