Events

Recall of IRT Screening Assay used for screening newborns for cystic fibrosis. 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-00087-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00087-1
  • 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
    For two lots of the irt screening assay kit (e-kr-480) there is a computer transcription error in the qc sheets for the value of standard 3, where the value is 50 µg/l instead of 60 µg/l. it has been determined via internal testing that if the cut-off value in use by the laboratory is 90 µg/l or higher, there is no risk of false positive results. for a cut-off value lower than 90 µg/l, the clinical impact depends on the cut-off value fixed by the laboratory/physician. so, depending on the cut-off value used, there may be a risk of a false positive result. as the irt screening assay is a screening test, all positive must be retested using a confirmatory method. thus, false positive patients will be retested with other tests (dna etc.) and found negative without harming the health of the patient being a false positive.
  • Action
    Abacus ALS is advising users that the correct value of Standard 3 is 50ug/mL (rather than 60ug/mL). The customer letter should be discussed with the Medical Director, with consideration given to the need for a look-back of results previously generated using the affected lots. This action has been closed-out on 01/03/2018.

Device

IRT Screening Assay used for screening newborns for cystic fibrosis. An in vitro diagnostic medic...
  • Model / Serial
    IRT Screening Assay used for screening newborns for cystic fibrosis. An in vitro diagnostic medical device (IVD).Reference Number: E-KR-480Lot Numbers: 013A & 016AARTG Number: 274979
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd