Events

Recall of UniCel DxC 800 PRO

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
    45960
  • Event Risk Class
    Class 2
  • Event Number
    Z-1101-2008
  • Event Initiated Date
    2007-04-05
  • Event Date Posted
    2008-05-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66589
  • 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
    Chemistry Analyzer (Discrete Photometric) - Product Code JJE
  • Reason
    Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or dxc instruments have been related to an intermittent failure of the stirrer motor. -stirrer motors can stall without any flags or motion errors. -if a stall occurs during a glum test near the time of sample inject, results may be affected. -affected glum results may be high or low.
  • Action
    GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.

Device

UniCel DxC 800 PRO
  • Model / Serial
    Part Number: A10407. All serial numbers. All software versions.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including Canada.
  • Product Description
    UniCel DxC 800 PRO Part Number: A10407, Beckman Coulter, Inc.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA