Recall of BD BACTED FX - Top Unit and Bottom Unit (used to detect bacteria and fungi in clinical specimens)

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
    Bd has determined that some db bactec fx instruments contain racks that may demonstrate variable indicator light intensities. specifically, the anonymous vial indicator lights, which should appear yellow, may instead appear green in colour. this has the potential to lead a user of the instrument to accidentally discard an anonymous vial or the readings associated with an anonymous vial, before an anonymous vial has completed protocol. the affected instruments continue to function properly and will not report an incorrect result.
  • Action
    BD is providing a software update to correct the issue, which will be available in February 2014. As an interim measure, BD is providing users with work around instructions to follow until the software upgrade is completed.


  • Model / Serial
    BD BACTED FX - Top Unit and Bottom Unit (used to detect bacteria and fungi in clinical specimens)BD BACTED FX - Top UnitReference Number: 441385Serial Numbers: FT2899, FT2914, FT2951 & FT3077BD BACTEC FX - Bottom UnitReference Number: 441386Serial Numbers: FB1724 & FB1756
  • Manufacturer