Events

Recall of CD8 (LEU 2A) REAGENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON CANADA INC..

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
    27988
  • Event Risk Class
    II
  • Event Initiated Date
    2014-12-29
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    May be hazardous to health: the cd8 pe reagent is contaminated with cd4 fitc. cd4 cells will be expressed along the fitc axis. any marker that is stained for on the fitc axis will contain this incorrectly stained cd4 population. with subsequent downgating the results will appear as if the cd4 population is not present. this could result in the unnecessary intensification of therapy for patients already known to have reductions in their cd4 levels.

Device

CD8 (LEU 2A) REAGENT
  • Model / Serial
    Model Catalog: 340046 (Lot serial: 4220622)
  • Product Description
    CD8 PE (LEU 2A) REAGENT
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.