Events

Recall of Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). 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 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-2017-RN-00063-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00063-1
  • 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 lots of the crag lfa have been found to have reduced specificity (90% now versus 99% before). the health risk only applies to patients with positive test results. a small number of samples with positive test results may not be true positives, which may cause some patients to initiate unnecessary anti-fungal therapy. samples with negative test results are not affected. the negative predictive value remains high at nearly 100%. there have been two customer complaints associated with this problem. there have been no reports of patient injury or death.
  • Action
    Abacus ALS is advising users to destroy stock from the affected lots to prevent further use. Replacement stock will be provided. Customers may decide to retest samples previously reported as positive using affected lots. Abacus ALS will provide replacement tests to perform retesting if this is required. This action has been closed-out on 01/03/2018.

Device

Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA). An in vitro diagnostic medical device (IVD).Kit Item Number: CR2003Lot Numbers: 161019161504NZ & 161007110553JGARTG Number: 272537
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd