Events

Recall of Cryostat Microtome, Thermo Scientific Microm HM 550 Cold Disinfection Cryostat

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Thermo Fisher Scientific.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57232
  • Event Risk Class
    Class 2
  • Event Number
    Z-1735-2011
  • Event Initiated Date
    2010-09-23
  • Event Date Posted
    2011-03-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97860
  • Notes / Alerts
    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.
  • Extra notes in the data
    Microtome, cryostat - Product Code IDP
  • Reason
    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
  • Model / 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.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    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.
  • Product Description
    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
  • Manufacturer Address
    Thermo Fisher Scientific, 4481 Campus Dr, Kalamazoo MI 49008-2590
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA