Events

Rappel de Cryostat Microtome, Thermo Scientific Microm HM 550 Cold Disinfection Cryostat

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Thermo Fisher Scientific.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    57232
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1735-2011
  • Date de mise en oeuvre de l'événement
    2010-09-23
  • Date de publication de l'événement
    2011-03-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97860
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Microtome, cryostat - Product Code IDP
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Thermo Fisher Scientific, 4481 Campus Dr, Kalamazoo MI 49008-2590
  • Société-mère du fabricant (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA