Events

Recall of BD Affirm VPIII Microbial Identification Tests (used for the testing of multiple infectious organisms). 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-2015-RN-00844-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-09-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00844-1
  • 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
    A portion of tests associated with the referenced lots/batches may exhibit blue speckles or fibres on the beads and cards. this issue would cause difficulty in interpreting test (control & patient) results across all beads. this would result in an invalid test.
  • Action
    BD is advising users to discontinue use and discard any remaining stock. This action has been closed-out on 17/08/2016.

Device

BD Affirm VPIII Microbial Identification Tests (used for the testing of multiple infectious organ...
  • Model / Serial
    BD Affirm VPIII Microbial Identification Tests (used for the testing of multiple infectious organisms). An in vitro diagnostic medical device (IVD)Catalogue Number: 446252Lot/Batch Numbers: 5135673, 5138774Expiry Date: 09/02/2016ARTG Number: 223745
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd