Events

Recall of Coxiella burnetii IFA IgG Kit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Abacus ALS 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-2016-RN-01149-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01149-1
  • 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
    Some coxiella burnetii ifa igg slides in kits from lot number 15c403 are labelled “leishmania infantum” instead of “coxiella burnetii”. the affected slides, while showing the inscription leishmania infantum, are coated with coxiella burnetii antigen and have the same features and performance as the slides labelled correctly with the coxiella burnetii inscription. of the slides checked by vircell, only 0.3% present with this labelling anomaly.
  • Action
    Abacus ALS is advising users to cease use of stock with the affected lot number. Abacus will replace affected stock with unaffected stock. A look back of previous results is at the discretion of the laboratory director. This action has been closed out on 13 Jun 2017.

Device

Coxiella burnetii IFA IgG Kit
  • Model / Serial
    Coxiella burnetii IFA IgG KitReference Number: PCOBUGKit Lot Number: 15C304Slide Lot Number: 15C403ARTG Number: 212957An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd