Events

Recall of Randox Liquid Assayed Specific Protein Controls. 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-2018-RN-00508-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00508-1
  • 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 have confirmed that free kappa light chains in certain liquid assayed specific protein controls increase over the shelf life of the product. the quality control results which are not within range can lead to a delay in reporting free kappa light chains results.Free kappa light chains are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for multiple myeloma through review of the ratio with free lamda chains. a short delay in reporting this result is unlikely to prevent diagnosis of these progressive diseases and therefore is unlikely to pose an immediate risk to health.
  • Action
    Randox is advising users to be aware of the issue and place the Customer Letter with any remaining kits. A revised IFU is also being supplied to users which outlines this issue to users under "Storage and Stability".

Device

Randox Liquid Assayed Specific Protein Controls. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Randox Liquid Assayed Specific Protein Controls. An in vitro diagnostic medical device (IVD). Catalogue Number: PS2682GTIN: 05055273204896Catalogue Number: PS2683GTIN: 05055273204902Catalogue Number: PS2684GTIN: 05055273204919ARTG Number: 199684
  • Manufacturer
    Randox Australia Pty Ltd

Manufacturer

Randox Australia Pty Ltd
  • Source
    DHTGA