Events

Recall of CellQuest Pro SW

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by BD Biosciences, Systems & Reagents.

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
    57613
  • Event Risk Class
    Class 2
  • Event Number
    Z-1845-2011
  • Event Initiated Date
    2007-09-07
  • Event Date Posted
    2011-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96797
  • 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
    Differential Cell Counter - Product Code GKZ
  • Reason
    Results and gates could be mismatched if you utilize the undo function to undo a gate that was deleted.
  • Action
    Important Product Information letters, dated September 2007, were sent the week of 9/14/2001 via Federal Express to all affected customers. The letters identified the affected product along with the reason for recall. The letter states that "as long as customers do not use the Undo function to undo a gate deletion, the software can be used with full functionality." The letter also states that BD will change the issue in the next software version. If customers believe that they may have analyzed sample files by utilizing the Undo function, then it is recommended that the sample files be re-analyzed. If customers need more information they should contact the Customer Support Center at 877-232-8995.

Device

CellQuest Pro SW
  • Model / Serial
    Catalog numbers: 343926, 339455, 343928, 347527, and 347526.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    CellQuest Pro SW, version 4.0.2. and later; || Becton Dickinson, San Jose, CA 95131 || CellQuest Pro software allows you to acquire and analyze data from your flow cytometer on a Macintosh computer.
  • Manufacturer
    BD Biosciences, Systems & Reagents

Manufacturer

BD Biosciences, Systems & Reagents
  • Manufacturer Address
    BD Biosciences, Systems & Reagents, 2350 Qume Dr, San Jose CA 95131-1812
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA