Events

Recall of Device Recall BD FACSDiva

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
    46372
  • Event Risk Class
    Class 2
  • Event Number
    Z-1530-2008
  • Event Initiated Date
    2007-12-21
  • Event Date Posted
    2008-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67312
  • 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 - IVD - Product Code GKZ
  • Reason
    Values might not update in statistics views after certain functions are performed in a worksheet.
  • Action
    The firm issued an Important Product Information notification letter on 12/21/2007. The letter instructs users to reload data by closing and reopening an experiment before reporting results in order to determine if their statistics have been impacted. They are asked to fill out and return a form pertaining to this problem. BD Biosciences will release a version of BD FACSDiva software to correct this problem. The letter also stated that BD Biosciences rep will contact the users when the new software is available. User are asked to contact BD Customer Support Center at 1-877-232-8995 if they have any additional questions.

Device

Device Recall BD FACSDiva
  • Model / Serial
    Material numbers 338960, 338962, and 339473
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    BD FACSDiva Software v6.0 and 6.1 with the HP XW4400 Computer System || Model/Catalog number 642685 || Software is used to simplify acquisition of flow cytometry data.
  • Manufacturer
    BD Biosciences

Manufacturer

BD Biosciences