Events

Recall of Pak Lx Assay

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-00056-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00056-1
  • 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
    Diagnostic solutions has been informed by lmmucor gti diagnostics that the conjugate diluent included in lots 3003658 and 3004022 has an expiration date defined on its labelling which is outside its supported stability. the expiration date for the conjugate diluent should be one year shorter than that provided on the labels.
  • Action
    Diagnostic Solutions is requesting users inspect their stocks and correct the expiry dates as per the new expiry dates given in the customer letter.

Device

Pak Lx Assay
  • Model / Serial
    Pak Lx AssayProduct Code: GT-PLXLot Number: 3003658with Conjugate Lot: 3003881Lot Number: 3004022with Conjugate Lot: 3003881ARTG Number: 217307
  • Manufacturer
    Diagnostic Solutions Pty Ltd

Manufacturer

Diagnostic Solutions Pty Ltd