Events

Recall of Device Recall Beckman Unicel DxC 600 and DxC 800 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
    55276
  • Event Risk Class
    Class 2
  • Event Number
    Z-2633-2011
  • Event Initiated Date
    2009-07-23
  • Event Date Posted
    2011-06-23
  • 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=90458
  • 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
    The recall was initiated because the wash concentrate tube assembly 142 may fail to deliver the appropriate amount of wash concentrate on some synchron dxc systems due to an accumulation of crystals. the impact of this issue would include: (1) quality control and patient results can potentially be affected. (2) if system has been calibrating properly and quality control is recovering within es.
  • Action
    Beckman Coulter sent out an "Urgent Product Corrective Action" letter dated July 23, 2009 and mailed the week of July 27, 2009 to all affected customers. The letter provides the cusotmers with explanation of the problem identifed and asks them to take the following actions: " If consignees are not able to resolve these issues through routine troubleshooting they were told to contact BCI Customer Technical Support at (800) 854-3633 in the United States and Canada. " This issue will be corrected with an upcoming software version and tubing modification. " Complete and return the enclosed response form within 10 days so that Beckman Coulter may maintain their records. Consignees were also asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Questions regarding this Product Corrective Action letter were directed to their Customer Technical Support Center (Hotline) at (800) 854-3633 in the United States and Canada.

Device

Device Recall Beckman Unicel DxC 600 and DxC 800 Clinical Systems
  • Model / Serial
    All serial numbers
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide) and Canada
  • Product Description
    Tubing Assembly #142, V2, V12 Mixer/Wash a component of || the DxC instruments. || Tube, Assembly, #142 V2, V12 Mixer/Wash delivers appropriate amount of wash concentrate on the UniCel DxC SYNCHRON Clinical Systems. The UniCel DxC 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