Events

Recall of EasyLink Data Management System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, 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
    71204
  • Event Risk Class
    Class 2
  • Event Number
    Z-1942-2015
  • Event Initiated Date
    2015-04-29
  • Event Date Posted
    2015-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136533
  • 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
    Calculator/data processing module, for clinical use - Product Code JQP
  • Reason
    System limitations and software issues related to the following features: custom reference ranges, user-initiated sample and result actions, auto-verification and quality control rules, and sample reports.
  • Action
    Siemens sent an Urgent Field Safety Notice (UMDC # ISW-15-01.A.US) on May 5, 2015 to all affected customers. The letter instructed customers to follow specific work around instructions, review this letter with their Medical Director, complete and return the Field Correction Effectiveness Check attached to this letter within 30 days, retain the letter with laboratory records, and forward it to those who may have received this product. For questions regarding this recall call 800-441-9250.

Device

EasyLink Data Management System
  • Model / Serial
    Catalog Numbers: 10444799, 10444800, 10487219
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Canada, Switzerland, Germany, Denmark, Spain, France, Hong Kong, Italy, Japan, Korea, Malaysia, Netherlands, Norway, New Zealand, Philippines, Portugal, Saudi-Arabia, Slovenia, and Taiwan.
  • Product Description
    EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA