Events

Recall of Immunoassay Premium and Premium Plus controls when used with ACTH assays. 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 Randox Australia 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-01067-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01067-1
  • 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
    Randox has confirmed that acth in immunoassay premium plus quality control and immunoassay premium quality control does not meet the quoted reconstituted stability claim in the product ifu. randox now recommends that acth is to be assayed immediately after the 30-minute reconstitution procedure.The quality control results which are not within range can lead to a delay in reporting acth results. acth is typically measured to aid in diagnosing the cause of abnormal cortisol. abnormal cortisol levels are generally not associated with immediate life threatening disorders. therefore a delay in acth reporting is unlikely to pose a serious risk to health.
  • Action
    1. Place a copy of the supplied notice in all impacted control kits, advising to assay ACTH immediately after the reconstitution procedure is complete. 2. Discuss the contents of the notice with the Medical Director.

Device

Immunoassay Premium and Premium Plus controls when used with ACTH assays. An in vitro diagnostic ...
  • Model / Serial
    Immunoassay Premium and Premium Plus controls when used with ACTH assays. An in vitro diagnostic medical device (IVD)Immunoassay Premium Quality ControlsCatalogue Number: IA2633Lot Numbers: 402366, 398703Immunoassay Premium Plus Quality ControlsCatalogue Number: IA3109 Lot Numbers: 1573EC, 1619EC Catalogue Number: IA3110 Lot Number: 1477ECCatalogue Number: IA3111 Lot Numbers: 1478EC, 1578ECCatalogue Number: IA3112Lot Number: 377412, 398901ARTG Number: 206767
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA