Recall of BD Vacutainer Heparin Tube. n 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
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    It has been reported that some tubes may contain an incorrect additive, potassium oxalate, instead of lithium heparin.The presence of potassium could result in falsely elevated potassium results and erroneous results for other analytes, which could lead to the misdiagnosis of serious illnesses.
  • Action
    BD is advising users to immediately discontinue the use of the affected units and quarantine any remaining affected stock and return for credit. This action has been closed-out on 02/05/2017.


  • Model / Serial
    BD Vacutainer Heparin Tube. n in vitro diagnostic medical device (IVD)Catalogue Number: 367885Lot Number: 5084266ARTG Number: 176053
  • Manufacturer