Events

Recall of FilmArray Blood Culture Identification (BCID) Panel when used with BD BACTEC Blood Culture Bottles. An in vitro diagnostic medical device.

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Biomerieux Australia 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-2018-RN-00271-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-04-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00271-1
  • 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
    Biomérieux australia has been advised that the manufacturer, biofire diagnostics, has identified an increased risk of false positive proteus results when the filmarray blood culture identification (bcid) panel is used with bd bactec blood culture bottles with expiration dates of september 30, 2018 and october 31, 2018. it is unknown if subsequent lots of media will also be subject to this risk; however, biofire and bd are continuing to investigate the issue.
  • Action
    bioMérieux is advising customers to verify positive results for Proteus by confirming with another method where BD BACTEC Blood Culture Bottles with expirations on 30/09/2018 and 31/10/2018 have been used due to the BCID Panel detecting nucleic acid from non-viable Proteus.

Device

FilmArray Blood Culture Identification (BCID) Panel when used with BD BACTEC Blood Culture Bottle...
  • Model / Serial
    FilmArray Blood Culture Identification (BCID) Panel when used with BD BACTEC Blood Culture Bottles. An in vitro diagnostic medical device. All lots of FilmArray Blood Culture Identification (BCID) Panel are impacted when used with specific BD media typesMultiple BD BACTEC Blood Culture Bottles with expiry dates of September 30 2018 and October 31 2018 may impact resultsARTG Number: 223979(Biomerieux Australia - Bacterial infectious disease IVDs)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd