Events

Retiro De Equipo (Recall) de Device Recall GEM Check Coag Whole Blood Controls

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 Corporation.

¿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
    56169
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2107-2010
  • Fecha de inicio del evento
    2010-07-08
  • 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=92829
  • 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 Control Plasma - Product Code GGN
  • Causa
    Certain lots of gem check coag whole blood controls contain an error in the package insert where the incorrect acceptable performance ranges were published.
  • Acción
    Urgent: Medical Device Correction Notices, dated July 1, 2010, were sent by Federal Express on July 8, 2010 to all first consignee end users. The letters identified the affected product and asked customers to review and follow all instructions as outlined in the ITC in the communication. The info should be shared with laboratory staff and the notification should be retained as part of the laboratory Quality System documentation. The enclosed response form should be completed and returned to ITC within 5 days.

Device

Device Recall GEM Check Coag Whole Blood Controls
  • Modelo / Serial
    Part Number 06260061600; Lot C9GC5001, Exp. 7/31/2010; G9GC5003, Exp 1/31/2011; J9GC5004, Exp 3/31/2011; and C0GC5001, Exp 10/31/2011.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including states of NY, TN, CA, AR, IL and TX and countries of Australia, Italy, Spain, Germany, Chile, Spain, Malta, Belgium, Austria, and Switzerland.
  • Descripción del producto
    GEM Check Coag CNTRL Normal APTT Whole Blood Controls Package Insert: || IVD. 15/pk. 06260061600. || Manufactured for: Instrumentation Laboratory Company, Lexington, MA 02421-3125. || Intended to be used to perform quality control assays using GEM test cartridges on the IL GEM PCL/PCL Plus Portable Coagulation Laboratory.
  • Manufacturer
    International Technidyne Corporation

Manufacturer

International Technidyne Corporation
  • Dirección del fabricante
    International Technidyne Corporation, 20 Corporate Pl S, Piscataway NJ 08854-6144
  • Empresa matriz del fabricante (2017)
    Werfenlife Sa.
  • Source
    USFDA