Events

Retiro De Equipo (Recall) de HemosIL von Willebrand Factor Activity Assay kit

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 Instrumentation Laboratory Co..

¿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
    61522
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1519-2012
  • Fecha de inicio del evento
    2012-04-11
  • Fecha de publicación del evento
    2012-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108339
  • 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
    Falsely elevated levels may be reported with the hemosil von willebrand factor activity assay.
  • Acción
    Instrumentation Laboratories mailed Recall Letter via USPS to US and Canadian customers on April 11, 2012, through Beckman Coulter. The customer mailing and tracking of the Urgent Recall Notification and Recovery Procedure in the United States and Canada will be handled through the distributor, Beckman Coulter. Accounts are requested to check inventory for the product lots of Hemosll von Willebrand Factor Activity, PN 0020004700, listed in the table and document their destruction on the provided tracking form and return the completed form. Questions or concerns regarding this notification, please call Beckman Coulter Technical Service at (800) 526-7694. On March 29, an e-mail communication was circulated to the IL Affiliates in Europe and Japan requesting them to translate the Urgent Field Safety Notification [title of document outside US and Canada] and product destruction tracking form, mail the notification to their customer base and notify their Competent Authorities.. Fpr questions regarding this recall call 781-861-4467.

Device

HemosIL von Willebrand Factor Activity Assay kit
  • Modelo / Serial
    Lot Numbers:  B01424 Exp Date: March 31 , 2012; B11498 Exp Date: July, 31 , 2012; B11655 Exp Date: November 30, 2012; B11687 Exp Date: January 31 , 2013
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Canada, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS BELGIUM, BRAZIL, CHILE, CHINA, CZECH REPUBLIC, DENMARK FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRAN (ISLAMIC REPUBLIC OF), ISRAEL, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF KUWAIT LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS NORWAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TURKEY, and the UNITED ARAB EMIRATES
  • Descripción del producto
    Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit || Part Number: 0020004700 || The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems
  • Manufacturer
    Instrumentation Laboratory Co.

Manufacturer

Instrumentation Laboratory Co.
  • Dirección del fabricante
    Instrumentation Laboratory Co., 180 Hartwell Road, Bedford MA 01730-2443
  • Empresa matriz del fabricante (2017)
    Werfenlife Sa.
  • Source
    USFDA