Events

Recall of Device Recall Cytomics Flow Cytometry System

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
    36397
  • Event Risk Class
    Class 2
  • Event Number
    Z-0197-2007
  • Event Initiated Date
    2006-07-26
  • Event Date Posted
    2006-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48584
  • 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
    Flow Cytometry System - Product Code GKZ
  • Reason
    Mis-identification-if a panel or protocol is added to an existing worklist but the tube location is not specified, the cxp acquisition software will run the last specified tube through the remaining protocols and will generate results and printouts of these runs leading to a mis-identification condition.
  • Action
    Customer letter -- A Product Corrective Action (PCA) letter was sent the week of July 24, 2006 to all accounts that have FC500 with CXP Software 2.0 and 2.1 to inform them that a potential sample misidentification may occur when running a Work list with missing tube Location(s) in Automatic MCL mode. The letter outlines actions to be taken to avoid mis-identification of patient results.

Device

Device Recall Cytomics Flow Cytometry System
  • Model / Serial
    Part Numbers: 722645 Software Kit; CXP version 2.1 New User; 723113 Software Kit; CXP version 2.1 Upgrade; 629637 Software Kit; CXP version 2.0 New User; 629636 Software Kit; CXP version 2.0 Upgrade; 626553 TN; FC500 WITH UPS; 6605627 TN; 5 CLR, FC500 (IOOV); 6605628 TN; 5 CLR, FC500 (120V); 6605629 TN; 5 CLR, FC500 (220V); 6605630 TN;5 CLR, FC500 (240V)
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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