Events

Recall of Device Recall Beckman Coulter UniCel DxC 880i, 860i, and 600i 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
    55173
  • Event Risk Class
    Class 2
  • Event Number
    Z-2590-2010
  • Event Initiated Date
    2010-02-25
  • Event Date Posted
    2010-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90219
  • 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
    Beckman coulter is initiating a recall on their unicel dxc clinical systems (880i, 860i,680i and 660i systems with serial number <2760 that have software version 4.9.01 installed and have the vme motorola ics board) because they may exhibit issues with stat sample rack loading, causing a possible delay in results.
  • Action
    Beckman Coulter sent an URGENT: FIELD SAFETY NOTICE letter, dated March 25, 2010, to all customers. The letter identified the affected product, the problem, and the actions customers take. Customers were instructed to: if the UniCel DxC system serial number was less than 2760 the customer should contact their local representative to arrange for an upgrade to software version 4.9 build 02. Complete and return the enclosed response form within 10 days of the notice. Share the information with their laboratory staff and retain the notification as part of the Quality System documentation. If affected products were forwarded to another laboratory, provide a copy of the notification letter to them. Customers may contact the Customer Support Center (Hotline) at 1-800-854-3633. For questions or comments please contact the firm at (714) 961-3634

Device

Device Recall Beckman Coulter UniCel DxC 880i, 860i, and 600i Systems
  • Model / Serial
    Software Part Number: A84500, A86646; Software version: 4.9.01; Serial Number <2760
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Class II Recall - USA, including the states of CA, IN, GA, NC, NY, OH, SC, and WI
  • Product Description
    UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software || version: 4.9.01 || The UniCel Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent)
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA