Events

Recall of cobas 4800 HPV Amplification/Detection Kit. 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 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-2017-RN-00625-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-05-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00625-1
  • 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
    Through routine quality stability monitoring, roche has been made aware that certain lots of the cobas 4800 hpv amplification/detection kit are generating an increase in the frequency of invalid positive control (pc) results, causing the entire run to be invalidated on the cobas 4800 system. as a precautionary measure, roche has additionally temporarily shortened expiration dates for other selected lots of these kits to reduce the potential for invalid pc result generation.
  • Action
    Roche Diagnostics is requesting users with affected lots (as reflected in Table 1 of the recall notification) to immediately discontinue use of and discard the indicated lots. Users with affected lots (as reflected in Table 2) are advised to be aware of and adhere to the revised expiry date of the indicated lots. (Users are to note that the cobas 4800 System will not recognise nor flag the revised expiry of the affected kits. Therefore, close attention must be paid to the expiry dates listed in Table 2 and appropriate action taken accordingly.) Users will be assisted with the process of supply of replacement kits.

Device

cobas 4800 HPV Amplification/Detection Kit. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    cobas 4800 HPV Amplification/Detection Kit. An in vitro diagnostic medical device (IVD)Material Numbers: 05235910190 and 05235901190Pack Size: 960 and 240 tests (respectively)Multiple Lot NumbersARTG Number: 187190
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited