Events

Recall of Device Recall Cytomics FC 500

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
    37083
  • Event Risk Class
    Class 2
  • Event Number
    Z-0418-2007
  • Event Initiated Date
    2006-08-29
  • Event Date Posted
    2007-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49884
  • 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
    cell analyzer - Product Code GKZ
  • Reason
    Two workflow scenarios associated with renaming regions may produce incorrect results.
  • Action
    A Product Corrective Action (PCA) letter was sent on the week of August 29, 2006 to all accounts that have an FC500 or have ordered CXP or MXP software to inform them that a) incorrect statistics are generated when a polygonal region with vertical re-entrant vertices is renamed using the Region Properties dialog box. b)when a region is copied from one plot to another, and then the new region is renamed, the statistics are not updated with the new region name. (Letter was sent by US mail). Letter includes immediate user preventive action to remedy both issues. A response form is included for consignees to return to recalling firm.

Device

Device Recall Cytomics FC 500
  • Model / Serial
    Part Numbers: 722645, 723113, 629637, 629636  Software, Versions 2.0 & 2.1
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide & Canada
  • Product Description
    Cytomics FC 500 with CXP software, Versions 2.0 & 2.1: Part #722645, Software Kit; CXP version 2.1 New User; Part #723113 Software Kit; CXP version 2.1 Upgrade; Part #629637 Software Kit; CXP version 2.0 New User; Part #629636 Software Kit; CXP version 2.0 Upgrade. The Cytomics FC 500 is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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