Events

Recall of Device Recall UniCel DxC 880i, 860i,680i and 660i Synchron Access 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
    55164
  • Event Risk Class
    Class 2
  • Event Number
    Z-2771-2011
  • Event Initiated Date
    2009-05-07
  • Event Date Posted
    2011-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90200
  • 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
    Antibody Radioassay - Product Code LIG
  • Reason
    The recall was initiated after beckman coulter confirmed reports of inaccurate access intrinsic factor ab test results displayed on, or printed from, the unicel dxl portion of an integrated workstation listed above. the problem is limited to numerical intrinsic factor ab results produced on integrated systems running unicel dxl system software version 4.0, 4.1, or 4.2. the dxc portion of your inte.
  • Action
    Beckman Coulter, Inc. sent out an "Urgent: Product Corrective Action" letter dated May 19, 2009 to all affected customers. The letter explained the reason for recall and provided recommendations including: -System software currently under development will correct this problem, and will be made available soon. Until then, please refer to UniCel DxC reports, user interface information, and LIS transmissions, which contain accurate Access Intrinsic Factor Ab test results. -Refer to the UniCel DxC system documentation for information on displaying and printing results from the DxC portion of an integrated workstation, or from your laboratory information system (LIS) -Past results for these assays only need to be reviewed if they were reported from the Dxl portion of an integrated workstation -Complete and return the enclosed response form For additional information please contact the Customer Technical Support at 1-800-854-3633, or your local Beckman Coulter representative.

Device

Device Recall UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems
  • Model / Serial
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: (USA) Nationwide including KY; and the country of Canada.
  • Product Description
    UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems || The Unicel DxC Integrated Workstation takes samples loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the Dxl analyzers according to the programming requirements
  • 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