Events

Recall of MultiSET

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

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
    45447
  • Event Risk Class
    Class 2
  • Event Number
    Z-0570-2008
  • Event Initiated Date
    2007-09-06
  • Event Date Posted
    2008-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65479
  • 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 Software - Product Code GKZ
  • Reason
    Inaccurate results: software error results in inaccurate display result statistics. if the user adjusts the lymph gate or attractors in the lab report view without using the manual gate function (as described in the system manual), the statistic results will not be updated to match the adjusted gate.
  • Action
    Becton Dickinson sent an Important Product Information letter by mail on 09/14/2007 informing customers of the need to follow the instructions for adjusting the lymph gate or attractors. The next software revision will alleviate this limitation.

Device

MultiSET
  • Model / Serial
    Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, Belgium, Brazil, Peru, Singapore, Canada, Jamaica, Chile, Ecuador, Hong Kong-China, Thailand, Mexico, Venezuela, Barbados, Philippines, Puerto Rico, Guatemala, Japan, Uruguay, Argentina, China, Trinidad and Tobago, Honduras, Australia, New Zealand, and India.
  • Product Description
    BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD Biosciences, San Jose, CA 95131.
  • Manufacturer
    BD Biosciences

Manufacturer

BD Biosciences