Retiro De Equipo (Recall) de Device Recall ACL TOP 700

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Instrument, coagulation, automated - Product Code GKP
  • Causa
    Potential for sample misidentification.
  • Acción
    Consignees were notified via phone starting on June 3, 2014. On June 4, a USPS mailing was sent to all US/Canadian customers. On June 4, 2014, email notifications were sent to the IL Affiliates and International Distributors/Dealers (through the International Group) requesting them to translate the Field Safety Notice and provide notification to their customer base and secondary distributors. The Urgent Product Correction letter informs consignees of the issue and provides workaround instructions. Consignees are asked to complete a Mandatory Response Tracking Record and return it via Fax (781)861-4207 or email: For technical questions, consignees should contact the IL Technical Support Center at 1-800-678-0710.


  • Modelo / Serial
    Start SN and Date: 09080100 Aug 2009 and End SN and Date 14050732 May 2014
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada, Mexico, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Brunei, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Quatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Venezuela, Vietnam.
  • Descripción del producto
    ACL TOP 700, automated coagulation laboratory instrument.
  • Manufacturer


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