Events

Recall of Device Recall Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1

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
    45945
  • Event Risk Class
    Class 3
  • Event Number
    Z-0958-2008
  • Event Initiated Date
    2007-06-29
  • Event Date Posted
    2008-04-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66549
  • 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
    Data generation error: if the cytosettings is not refreshed or restarted during data importation, the output will include old and new data.
  • Action
    Consignees were notified by an Urgent Product Corrective Action letter sent on 6/29/07. The letter provided details on the data error and instruction on how to avoid the error. Users were asked to retain notification as part of the Quality Systems documentation and return a response form acknowledging receipt. For additional information, contact 1-800-526-7694.

Device

Device Recall Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1
  • Model / Serial
    Serial numbers: AJ50363, AK25191, AK39273, AJ30194AK02009, AK24144, AJ32209, AL13073, AJ43303, AK32209, AJ50358, AL17100, AK24164, AJ47338, AJ13070, AL06029, AJ13071, AK32212, AK32210, AJ39264, AJ43304
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- USA and country of Canada.
  • Product Description
    Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1, Automated differential cell counter, Part Number: 626554, Beckman Coulter, Fullerton, CA 92834
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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