Events

Recall of CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro. 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-00415-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00415-1
  • 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 has discovered that in rare cases (<0.00015%) an “error 6” may also be displayed by individuals who are under treatment with warfarin in combination with antibiotics and/or chemotherapeutics. in such patients inr values could be extremely high (>10 inr). the coaguchek displays the various codes when it suspects there could be a problem with the actual measurement of your inr. "error 6” when shown in the display represents alerts to a number of issues with the testing.
  • Action
    In the event of an "error 6" end users are advised to repeat the test and if the error continues contact their physician immediately. The package insert for the CoaguChek XS PT strips will be updated to contain this information. For more information, please see http://www.tga.gov.au/safety/alerts-device-coaguchek-inr-monitors-130516.htm .

Device

CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro. An in vitro diagnostic medical device (IVD)Material numbers: 04796179001, 04811500001, 04963733001, 06505597001, 04800842190, 05864640001, 06505589001, 06644511001, 05530199190
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited