Events

Recall of BBL MGIT Mycobacteria Growth Indicator Tube(used for the detection and recovery of mycobacteria including mycobacterium tuberculosis)

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-00975-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-09-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00975-1
  • 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
    Bd has determined that affected bbl mgit tubes were labelled with an incorrect barcode, such that the correct barcode prefix "43 01" was actually printed as "43 02". the manufacturer identified this error prior to supplying the product and over labelled the product with the correct barcode. the manufacturer has identified that the over labels may peel off in varying degrees which exposes the incorrect barcode. this can result in mgit false negative results.
  • Action
    BD is requesting users to discontinue use and discard any remaining inventory of the affected product. Replacement stock will be provided by BD. The package insert recommends that users perform a visual check of all instrument negative tubes. Tubes that appear to be positive should be sub-cultured, acid-fast stained and treated as a presumptive positive. A review of previously reported results is not required if this protocol is followed.

Device

BBL MGIT Mycobacteria Growth Indicator Tube(used for the detection and recovery of mycobacteria i...
  • Model / Serial
    BBL MGIT Mycobacteria Growth Indicator Tube(used for the detection and recovery of mycobacteria including mycobacterium tuberculosis)Catalogue Number: 245122Lot Number: 3061013Expiry date: 6 September 2014An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd