Events

Recall of Device Recall Cytomics FC500 with CXP 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
    34247
  • Event Risk Class
    Class 2
  • Event Number
    Z-0380-06
  • Event Initiated Date
    2005-11-23
  • Event Date Posted
    2006-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43332
  • 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
    Analyzer, Chemistry, Micro, For Clinical Use - Product Code JJF
  • Reason
    Under certain conditions an incorrect tube id (barcode) can be displayed and printed on the runtime panel report in cxp cytometer software version 2.0.
  • Action
    A Product Corrective Action letter will be mailed the week of Nov 28, 2005 to all FC500 wi CXP Software customers. Each user will be contacted initially and then once more (if needed) in order to determine the rate of response from the Response form provided.

Device

Device Recall Cytomics FC500 with CXP Software

Manufacturer

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