Events

Recall of UniCel DxC 600/800 with

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
    63143
  • Event Risk Class
    Class 2
  • Event Number
    Z-0123-2013
  • Event Initiated Date
    2012-09-03
  • Event Date Posted
    2012-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112676
  • 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 has confirmed that the shuttle to barcode reader and cap piercer alignment procedure cannot be performed on certain dxc configurations with v5.0.11 software installed. if the shuttle to barcode reader becomes misaligned, the operator will not be able to perform this alignment procedure on the dxc systems listed above. software v5.0 .11 does not allow access to the shuttle to bar.
  • Action
    Beckman Coulter sent an Urgent Field Safety Notice dated August 30, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that their Beckman Coulter Service Representative would contac them to reinstall the software. Customers were asked to complete and return the enclosed Response Form. For questions customers were instructed to call their Customers Support Center on the Beckman Coulter website at www.BeckmanCoulter.com/CustomerSupport/SupportRequest. For questions regarding this recall call 714-993-5321.

Device

UniCel DxC 600/800 with
  • Model / Serial
    Part Number B12218. Serial numbers 2329, 5477, 5479.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including TX and OH. Interntionally to China and Turkey
  • Product Description
    UniCel¿ DxC 600/800 with || Software v5.0.11, Part Number B12218. || The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, computercontrolled 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., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA