Events

Recall of Cobas 4800 HPV Amplification/Detection Reagents, 240 tests and 960 tests240 tests

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-2013-RN-00752-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-07-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00752-1
  • 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
    During an internal investigation, a formulation error was identified during the manufacture of the cobas 4800 hpv master mix reagent leading to an increased rate of invalid runs. this issue does not cause incorrect specimen results, however results from failed runs must be repeated.
  • Action
    Roche is requesting users to discontinue use and discard all units from the affected lots. Roche will replace any affected units.

Device

Cobas 4800 HPV Amplification/Detection Reagents, 240 tests and 960 tests240 tests
  • Model / Serial
    Cobas 4800 HPV Amplification/Detection Reagents, 240 tests and 960 tests240 testsPart Numbers: 05235901190Lot Numbers: R15771 960 testsPart Numbers: 05235910190Lot Numbers: R15304
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited