Events

Recall of EliA IgG Conjugate. 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-2016-RN-00599-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-05-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00599-1
  • 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
    Investigation of complaints received has concluded that when using elia ccp well (14-5515-01) in combination with elia igg conjugate (83-1017-01, 83-1005-01, 83-1002-01 or 83-1018-01), anti-ccp-signals can be elevated for the listed conjugate lots.The positive bias of the elia ccp test will change a small percentage of test results from negative to equivocal and equivocal or high negative to low positive.Testing on clinical samples of both confirmed rheumatoid arthritis (ra) patient sera, healthy blood donors and other disease controls resulted in < 1% of the samples changing from negative to positive, according to current cut-off ranges (total study includes 472 samples). the results of the assay evaluation studies performed confirm the variance to be within current clinical performance, and it is concluded that the clinical impact of the observed bias is negligible.
  • Action
    The sponsor is advising customers to stop using EliA CCP Well (14-5515-01) in combination with EliA IgG Conjugate (83-1017-01, 83-1005-01, 83-1002-01 or 83-1018-01) of the affected lots as stated. The sponsor will provide unaffected EliA IgG conjugate lots as soon as they become available. This action has been closed-out on 15/02/2017.

Device

EliA IgG Conjugate. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    EliA IgG Conjugate. An in vitro diagnostic medical device (IVD).EliA IgG Conjugate 50Article Number: 83-1017-01EliA IgG Conjugate 200Article Number: 83-1018-01EliA IgG ConjugateArticle Number: 83-1005-01 EliA IgG ConjugateArticle Number: 83-1002-01Multiple Lots and Kits affectedARTG Number: 229585
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd