Events

Recall of PF4 IgG assay (Thrombophilia and coagulation inhibitor assay). 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 Diagnostic Solutions 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-2014-RN-01342-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01342-1
  • 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 has determined that the pf4 concentrated wash (10x) lots indicated in this letter were manufactured at a slightly more dilute concentration. this may result in slightly increased optical density (positive bias) values with results generated using these buffer lots.
  • Action
    Diagnostic Solutions is requesting their customers to discard the affected kits. Replacement reagents will be provided. This action has been closed-out on 14/07/2016.

Device

PF4 IgG assay (Thrombophilia and coagulation inhibitor assay). An in vitro Diagnostic Medical Dev...
  • Model / Serial
    PF4 IgG assay (Thrombophilia and coagulation inhibitor assay). An in vitro Diagnostic Medical Device (IVD).Lot Numbers: 3001992 & 3002227ARTG Number: 217308
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd