Events

Recall of UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter 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
    74569
  • Event Risk Class
    Class 2
  • Event Number
    Z-2272-2016
  • Event Initiated Date
    2014-04-22
  • Event Date Posted
    2016-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147928
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    Possible leaking of no foam solution from the no foam bottle assembly on the unicel dxc synchron systems.
  • Action
    An Important Product Notice dated 4/22/14 was sent to all their customers to inform them that Beckman Coulter has identified a manufacturing issue with a plastic fitting on the No Foam Bottle Assembly which may crack and cause No Foam solution to leak. The letter informs the customers of the impact, action to be taken, and resolution. Customers are asked to inspect the No Foam Bottle Assembly for leaks prior to refilling the bottle. If leaks occur, customers should contact Customer Support Center following the instructions provided. Customers are instructed to complete the enclosed response form within 10 days. Customers with questions are instructed to contact the firm's Customer Support Center - Via our website, http://www.beckmancoulter.com/customersupport/support - Via phone, call 1-800-854-3633 in the United States and Canada - Outside the United States and Canada, contact your local Beckman Coulter Representative.

Device

UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems
  • Model / Serial
    Up to and including 6133
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United Arab Emirates, Angola, Australia, Belgium, Bulgaria, Canada, Switzerland, China, Colombia, Costa Rica , Czech Republic, Germany, Denmark, Egypt, Eritrea, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Ireland, India, Italy, Jordan, Japan, Korea, Republic of, Kuwait, Lebanon, Lithuania, Morocco, Mexico, Malaysia, Namibia, Netherlands, Norway, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Serbia, Russian Federation, Rwanda, Saudi Arabia, Sweden, Singapore, Slovakia, Swaziland, Thailand, Tunisia, Turkey, Taiwan, US (including Puerto Rico), Vietnam, South Africa, and Zimbabwe.
  • Product Description
    UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems || The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from the No Foam Bottle to the Waste B canister and the Waste Manifold on the DxC Hydro System. || Catalog No. || UniCel DxC 800 Synchron Clinical Systems || UniCel DxC 600 Synchron Clinical Systems || UniCel DxC 600i Synchron Access Integrated Clinical Systems || UniCel DxC 880i Synchron Access Integrated Clinical Systems || UniCel DxC 660i Synchron Access Integrated Clinical Systems || Product Labeling Reference No. A93719 || For the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA