Events

Recall of Device Recall EasyLink Informatics System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dade Behring, Inc..

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
    38384
  • Event Risk Class
    Class 2
  • Event Number
    Z-1174-2007
  • Event Initiated Date
    2007-07-03
  • Event Date Posted
    2007-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53520
  • 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
    Information system - Product Code JJE
  • Reason
    Sample id and patient results could be associated with the wrong patient.
  • Action
    The recalling firm issued a Field Corrective Action letter dated 7/3/07 to inform their customers of the problem and that a software patch would be sent for them to download. The recalling firm plans to telephone the customers after the patch has been released to verify that it has been installed.

Device

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.

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