Events

Recall of Device Recall BD CD4 (SK3) FITC

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton, Dickinson and Company, 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
    72071
  • Event Risk Class
    Class 3
  • Event Number
    Z-2817-2015
  • Event Initiated Date
    2015-08-27
  • Event Date Posted
    2015-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139712
  • 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
    Counter, differential cell - Product Code GKZ
  • Reason
    Cd4 fitc label contains an error in the spanish small text - it states cd8 fitc.
  • Action
    Urgent Product Recall notification letters were sent to each customer on August 27, 2015 by certified mail.

Device

Device Recall BD CD4 (SK3) FITC
  • Model / Serial
    Catalog Number 340133; lot # 5112711, Expiration date: 30 Nov 2016.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US nationwide (TX, CA, NC, OH, SD, PA, CT, UT, MD, TX, GA), Argentina, Taiwan, Australia, Japan, China, New Zealand, Chile and Colombia.
  • Product Description
    CD4 (SK3), FITC; || Contains CD4 FITC with gelatin and 0.1% sodium Azide. || Catalog number 340133 || in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on monocytes. CD4 is a receptor for the human immunodeficiency virus (HIV).
  • Manufacturer
    Becton, Dickinson and Company, BD Biosciences

Manufacturer

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