Events

Recall of ONLINE DAT Cannabinoids II / 100 tests / 200 testsLot numbers: 698113, 604195, 604194, 696131, 698110 & 696133

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

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-2015-RN-00157-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-03-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00157-1
  • 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
    Internal investigations by roche diagnostics verified that the within run precision (cv) for the positive/negative control with different reagent lots is approximately 10%. the specification is lower than 8%. patient sample results which are very close to the cutoff might recover below the cutoff. the affected reagent lots expire in may 2015. newer lots are not affected by the precision issue and can be used as a replacement.
  • Action
    Roche is requesting their customers to discard any remaining stock of THC II from reagent lots 69811301 and 60419501. This action has been closed-out on 02/03/2016.

Device

ONLINE DAT Cannabinoids II / 100 tests / 200 testsLot numbers: 698113, 604195, 604194, 696131, 69...
  • Model / Serial
    ONLINE DAT Cannabinoids II / 100 tests / 200 testsLot numbers: 698113, 604195, 604194, 696131, 698110 & 696133 ARTG number: 174911
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited