Events

Recall of Device Recall ThermoFisher Scientific Microm STP 420D

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
    52175
  • Event Risk Class
    Class 2
  • Event Number
    Z-1320-2010
  • Event Initiated Date
    2009-06-03
  • Event Date Posted
    2010-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82412
  • 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
    Processor, tissue, automated - Product Code IEO
  • Reason
    The firm has received complaints regarding specimen integrity (higher rate of specimen fragmentation) as well as complaints that the chamber may stop rotating prematurely, resulting in sample deterioration.
  • Action
    Consignees were notified of the problem by letter, on or about 6/3/09, updating the instructions for use. The units were subsequently upgraded on or before 9/8/09. For additional questions and information, please contact ThermoFisher's Technical Support department , Subject: PT Module Advisory Notice.

Device

Device Recall ThermoFisher Scientific Microm STP 420D
  • Model / Serial
    All units.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Hawaii, Kentucky, Louisiana, Michigan, Missouri, Nebraska, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and West Virginia.
  • Product Description
    ThermoFisher Scientific Microm STP 420D automated tissue processor.
  • 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