Events

Retiro De Equipo (Recall) de HemosIL RecombiPlasTin 2G,

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
    65399
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1784-2013
  • Fecha de inicio del evento
    2013-04-09
  • Fecha de publicación del evento
    2013-07-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-05-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118777
  • 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, time, prothrombin - Product Code GJS
  • Causa
    Instrumentation laboratory is recalling hemosil recombiplastin 2g (rpt2g), part no. 0020009580 (8 ml size) due to being out of specification.
  • Acción
    Between April 9, 2013 and April 11, 2013, Instrumentation Laboratory distributed "Important Product Correction" notification letters to their U.S. and foreign customers informing them that the on-board instrument stability claim has been reduced to 3 days for all current and future product lots of HemosIL RecombiPlasTin 2G. A second notification to non-respondents was initiated and completed on May 7, 2013. Technical questions were referred to 1-800-678-0710, Option # 2.

Device

HemosIL RecombiPlasTin 2G,
  • Modelo / Serial
    Part Number applies to all: 0020002950 - all product lots.  Lot Numbers: 1) N0716706 Exp. Date 5/31/2013, 2) N0817321 Exp. Date 5/31/2013, 3) E0917396 Exp. Date 9/30/2013, 4)) N0917378 Exp. Date 9/30/2013, 5) N1118029 Exp. Date 10/31/2013, 6) N0128669 Exp. Date 1/31/2014, 7) N0329291 Exp. Date 2/28/2014, 8) N0429596 Exp. Date 3/31/2014, 9) N0520056 Exp. Date 5/31/2014,10) E0720822 Exp. Date 7/31/2014, 11) N0821174 Exp. Date 8/31/2014, 12) N091388 Exp. Date 9/30/2014, 13) N0921522 Exp. Date 9/30/2014, 14) N0132676 Exp. Date 1/31/2015 and 15) N1222567 Exp. Date 1/31/2015.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution- US (nationwide) including states of: MA, ME, CT, NJ, NY, PA, MD, VA, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, MT, IL, MO, KS, NE, LA, AR, OK, TX, CO, ID, AZ, CA, OR, WA, AK, RI, VT and the countries of: Angola, Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Bulgaria, Canada, Caribbean, Chile, Colombia, Costa Rica, Czech, Denmark, Dubai, Ecuador, Egypt, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hungary, India, Indonesia, Iran, Israel, Italy, Jamaica, Jordan, Korea, Kosovo, Kuwait, Lebanon, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Turkey, Ukraine, Uruguay, Vietnam, and Japan.
  • Descripción del producto
    HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.
  • 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