Events

Recall of ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. 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-2017-RN-00169-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00169-1
  • 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
    Abc1 hla typing trays included in a single lot of acb1/acb2 kits contain a manufacturing defect that can result in false positive or false negative results.
  • Action
    Diagnostic Solutions is advising customers to immediately discontinue use of and destroy ABC1 HLA Typing Trays from the affected lot. Replacement kits will be provided. It is recommended that previously reported results are reviewed at the discretion of the clinical or laboratory director. This action has been closed out on 16 June 2017.

Device

ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    ABC1 HLA Typing Tray included in ABC1 / ABC2 Kits. An in vitro diagnostic medical device (IVD).Product Code: GT-ABC1/2AULot Number: 3004753Expiration Date: 15 Nov 2017ARTG Number: 236406
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd