Devices

Device Recall EasyLink Informatics System

  • Model / Serial
    Part number 1000034941
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide: USA including states of AZ, CA, FL, IL, MA. MI, MO, NC, OH, PA, TX, and WV. The product was also shipped to other Dade facilities in MO, DE, IL, CT, and Belgium.
  • Product Description
    EasyLink Informatics System, software version 3.0, Part Number 1000034941, DADE BEHRING INC., Newark, DE.
  • Manufacturer
    Dade Behring, Inc.
  • 1 Event

Manufacturer

Dade Behring, Inc.
  • Manufacturer Address
    Dade Behring, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall EasyLink Informatics System
  • Model / Serial
    Version 5.0 and Version 5.0 Service Pack 1 through 4
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including the countries of Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, New Zealand, Slovakia, Spain, Switzerland and the United States, with nationwide distribution. Center Recall Depth is Retail.
  • Product Description
    EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.
Device Recall EasyLink Informatics System included with the Dimension Vista System
  • Model / Serial
    Part Number: 1000046623.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, Portugal, Slovenia, Spain and Switzerland.
  • Product Description
    EasyLink Informatics System included with the Dimension Vista System. || The Dimension Vista Integrated System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.