Events

Recall of Device Recall CXP analysis SW V2.1, 10 network user with Romlock

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
    46287
  • Event Risk Class
    Class 2
  • Event Number
    Z-2024-2008
  • Event Initiated Date
    2007-05-04
  • Event Date Posted
    2008-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67140
  • 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
    Incorrect display: in certain modes, the protocol will not initially display the correct data in some plots. in addition, when running ewl files, any edited sampleid1 is not automatically updated in all tubes in the panel.
  • Action
    Consignees were notified of this safety recall by an Urgent Product Corrective Action letter sent on 5/3/07. The letter provided instructions on how to ensure correct data acquisition. Users were requested to return a response form acknowledging receipt of the letter. For additional information contact 1-800-526-7694.

Device

Device Recall CXP analysis SW V2.1, 10 network user with Romlock
  • Model / Serial
    Part Number 722594
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution including USA and country of Canada.
  • Product Description
    Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 10 network user with Romlock, Automated differential cell counter; Part Number 722594; Beckman Coulter; Miami, FL 33196.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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