Events

Retiro De Equipo (Recall) de Device Recall Hemocrhon Jr APTT Cuvettes

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 ITC-Nexus Dx.

¿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
    68659
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2088-2014
  • Fecha de inicio del evento
    2014-06-20
  • Fecha de publicación del evento
    2014-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128402
  • 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
    System, multipurpose for in vitro coagulation studies - Product Code JPA
  • Causa
    Test results may be erroneously elevated or report an out-of-range high (oor-h) error code in non heparinized blood samples.
  • Acción
    ITC issued an Urgent Medical Device Recall Letters/Response Forms dated June 20, 2014, to End-users and US Distributors were notified. ITC asks that this communication be forwarded to all those within your organization who need to be aware of this matter. If any affected products have been forwarded to another facility, a copy of this communication should be forwarded to them immediately. Customers should check their inventory for the affected lot. The affected lot should not be used and quarantined until return to ITC. The attached form should be completed and returned to ITC within 10 days. ITC will review the form and contact the customer to coordinate any returns. For questions, please contact Technical Support: Telephone 732-548-5700, Extension 4011 E-mail: Techsupport@itcmed.com Normal business hours are Monday through Friday, 8:00 AM to 6:30 PM, Eastern Time.For urgent matters, Technical Support is available 24 hours per day, 7 days a week.

Device

Device Recall Hemocrhon Jr APTT Cuvettes
  • Modelo / Serial
    Lot Number A4JCA001
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.
  • Descripción del producto
    Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
  • Manufacturer
    ITC-Nexus Dx

Manufacturer

ITC-Nexus Dx
  • Dirección del fabricante
    ITC-Nexus Dx, 23 Nevsky St, Edison NJ 08820-2425
  • Empresa matriz del fabricante (2017)
    Samsung Electronics Co., Ltd.
  • Source
    USFDA