Events

Recall of FC 500 with CXP Acquisition Software

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
    49010
  • Event Risk Class
    Class 2
  • Event Number
    Z-0455-2009
  • Event Initiated Date
    2007-08-01
  • Event Date Posted
    2009-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72513
  • 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
    Automated Differential Cell Counter - Product Code GKZ
  • Reason
    Software error: the recall was initiated after beckman coulter identified that the cxp user documentation does not adequately characterize the use of the live gate feature. the primary use of a live gate is for the international removal of unwanted events, such as debris. the data outside of the live gate will not be stored to the final listmode file, this reducing the data set size. the softwa.
  • Action
    The customer notifications were initiated by Beckman Coulter on July 23, 2007 when a Product Corrective Action (PCA) was mailed via US Postal Service to all affected customers. The PCA informed the customers that the user documentation does not adequately characterize the use of the Live Gate feature. The letter provides the customer with explanation of Live Gate and actions to be taken. For further information, please contact Beckman Coulter, Inc. by telephone at 714-993-5321.

Device

FC 500 with CXP Acquisition Software
  • Model / Serial
    Part Numbers 626553, Version 2.2
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Globally to the United States and Canada.
  • Product Description
    Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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