Events

Recall of Device Recall BD MultiCheck CD4 Low Control

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
    68892
  • Event Risk Class
    Class 3
  • Event Number
    Z-2233-2014
  • Event Initiated Date
    2014-07-18
  • Event Date Posted
    2014-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128967
  • 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
    The outer box label contains the incorrect distribution date: box states 2017-09-02 ; should be 2014-09-02.
  • Action
    Global hold initiated on July 18, 2014. Customer letters sent by certified mail on July 18, 2014 to advised users of the problem.

Device

Device Recall BD MultiCheck CD4 Low Control
  • Model / Serial
    Catalog number 340916; Lot number BM084L
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    IN, MA, TX, VA, Ca, KY, MD, PA, GA, and BD locations in Singapore and Belgium
  • Product Description
    BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
  • 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