Events

Retiro De Equipo (Recall) de Cryostat Microtome, Thermo Scientific Microm HM 550 Cold Disinfection Cryostat

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 Thermo Fisher Scientific.

¿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
    57232
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1735-2011
  • Fecha de inicio del evento
    2010-09-23
  • Fecha de publicación del evento
    2011-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97860
  • 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
    Microtome, cryostat - Product Code IDP
  • Causa
    Through internal quality review, firm determined the need to conduct a more comprehensive system validation to support the claim of complete bacterial, fungal and viral disinfection efficacy.
  • Acción
    ThermoFisher sent Advisory Notice letters beginning on September 28, 2010, to all affected customers. The letters stated that the firm needed to conduct more comprehensive system validation data on the Cold-Disinfection sytem option available on the HM550-D cryostat to support the claim of complete bacterial, fungal and viral disinfection efficacy. The letter recommended that the Cold Disinfection option on the HM550-D not be used as the sole disinfection method on the HM550-D until the validation work is completed. The firm provided addtional safety protocols pertaining to the cryostat disinfection. Customers were instructed to complete and fax the Confirmation of Receipt Form to Technical Support, COLD-D Advisory Notice at (269) 372-2436.

Device

Cryostat Microtome, Thermo Scientific Microm HM 550 Cold Disinfection Cryostat
  • Modelo / Serial
    Upgrade 37379, Upgrade 40963, Upgrade 41256, 47686, 47778, 47927, 47981, 48018, 48019, 48052, 48053, 48125, 48126, 48127, 48352, 48559, 46594, 47048, 47064, 47213, 47226, 47737, 47738, 47874, 47875, 48228, 48229, 48355, 48356, 46607, 46608, 48350, 46605, 47693, 48629, 48022, 48227, 48134, 46823, 46824, 48716, 43642.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including the states of LA, OH, FL, MD, PA, TX, MO, WI, KS, AL, CA, VA, MS, IL, NE, MA, and the countries of Australia, Belgium, China, Czech Republic, Denmark, Estonia, Finnland, France, Germany, Hong Kong, India, Italy, Japan, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Taiwan, and the UK.
  • Descripción del producto
    Thermo Scientific HM 560 Cold Disinfection Cryostat, Microm International GmbH, Waldorf, Germany || Tissue processing equipment used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific
  • Dirección del fabricante
    Thermo Fisher Scientific, 4481 Campus Dr, Kalamazoo MI 49008-2590
  • Empresa matriz del fabricante (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA