Events

Recall of HLA-B27 SYSTEM

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
    72450
  • Event Risk Class
    II
  • Event Initiated Date
    2013-03-21
  • 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
    The hla-b27 fitc/cd3 pe reagent in the bdt hla-b27 kits is contaminated with cd4 pe and expresses itself as a presence of an additional dim cd3+ monocyte population (noted in the red circle of image provided in the customer letter) and a split in the bright cd3 population which prevented the software to gate on facscanto instruments. (this could in rare circumstances lead to a false positive result. gating failure would result in the inability to generate a result and thus cause a delay in the diagnostic process).

Device

HLA-B27 SYSTEM
  • Model / Serial
    Model Catalog: 340183 (Lot serial: 3035581); Model Catalog: 340183 (Lot serial: 3029914)
  • Product Description
    BD HLA-B27 Kit
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.