Events

Recall of BD HLA-B27 Kit (An in vitro diagnostic medical device (IVD))

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Becton Dickinson Pty Ltd.

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
    RC-2013-RN-00249-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-03-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00249-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The hla-b27 fitc/cd3 pe reagent in the bd hla-b27 kits is contaminated with cd4 pe. this results in an apparent elevated cell population.
  • Action
    Laboratories are requested to discard all remaining stock from the affected lot of HLA-B27 kit.If the affected lot has been used, laboratories are requested to review and examine all data files for possible incorrect CD3 staining due to the contamination with CD4. Unless confirmatory testing has already been conducted, positive samples should be tested using an alternative method.

Device

BD HLA-B27 Kit (An in vitro diagnostic medical device (IVD))
  • Model / Serial
    BD HLA-B27 Kit (An in vitro diagnostic medical device (IVD))Catalogue Number: 340183Unit: KitLot Number: 3029914ARTG Number: 192529
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd