Events

Recall of Cortisol Saliva ELISA. 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-2018-RN-00109-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00109-1
  • 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
    The manufacturer, ibl has detected an issue that indicates a degradation in performance of the kit resulting in elevated cortisol values. when testing patient samples with one of the affected lots, the controls and calibrator values will meet specifications; however, due to a degradation in the starting concentration of the calibration standards, the calculated results for individual patient samples may be higher compared to lc-ms/ms measurements and may trigger unnecessary additional testing.A review of additional data comparing the respective kit standards of the lots to lc-ms/ms data it is evident that the lots eco142 to eco143 generate elevated results:- eco142 (passing bablok fit (y=0.009988 + 1.549x)- eco143 (passing bablok fit (y=0.003142 + 1.623x)there has not been any reports of injuries associated with this issue.
  • Action
    Abacus is advising users to inspect stock and quarantine any remaining stock of the affected batches. Affected product will be replaced with unaffected stock. A review of previously generated patient results is at the discretion of the Laboratory Director.

Device

Cortisol Saliva ELISA. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Cortisol Saliva ELISA. An in vitro diagnostic medical device (IVD)Catalogue Number: RE52611Lot Numbers: ECO142, ECO143Expiry Dates: ECO142: 2018-02-28; ECO143: 2018-12-31ARTG Number: 210636 (Abacus ALS - Clinical chemistry hormone IVDs)
  • Manufacturer
    Abacus ALS Pty Ltd

Manufacturer

Abacus ALS Pty Ltd