Events

Recall of cobas 4800 PCR Media Kit, cobas 4800 PCR Urine Sample Kit and cobas PCR Female Swab 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-2013-RN-01363-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01363-1
  • 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
    Roche diagnostics australia would like to inform users of the possibility of leakage occurring for some batches of cobas® pcr media ivd. these are packaged into different lots via the cobas pcr urine ivd kits and cobas pcr female swab ivd kits.
  • Action
    Roche is requesting their customers to continue to follow the instructions for use and to inspect each tube or blister pack for evidence of leakage. If leakage is detected the media must be discarded.

Device

cobas 4800 PCR Media Kit, cobas 4800 PCR Urine Sample Kit and cobas PCR Female Swab Kit. An in vi...
  • Model / Serial
    cobas 4800 PCR Media Kit, cobas 4800 PCR Urine Sample Kit and cobas PCR Female Swab Kit. An in vitro diagnostic medical device (IVD)Part Numbers/lot numbers: 05170486190/S01885 & earlier (except S01884) and 05170516190/S10487 & earlier
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited