Events

Recall of Combur10 Test UX when measured on Urisys 1100. 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-2018-RN-00349-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00349-1
  • 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 changed the performance claims for the combur10 test ux when measured on the urisys 1100 analyser.Roche performed internal performance studies, in order to maintain products’ compliance to current regulatory requirements. these studies determined that the limit of detection (lod) of certain parameters when measured on the urisys 1100 analyser varied from the claims stated in the ifu current at the time of testing.Parameters with changed lod are: protein, nitrite, ketone bodies, leukocytes, and blood: intact erythrocytes. note:values for all other parameters measured by the combur10 test ux remain unchanged.The lower lod for visual reading remains unchanged for all parameters.Roche has received no customer complaints worldwide in relation to this issue.
  • Action
    Roche is advising users to verify negative results for Protein, Nitrite, Ketone bodies, Leukocytes or Blood (intact erythrocytes), by visual reading, using the colour scale provided on the test strip vial. In case of discrepant values, the visually determined value shall be reported.

Device

Combur10 Test UX when measured on Urisys 1100. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Combur10 Test UX when measured on Urisys 1100. An in vitro diagnostic medical device (IVD)Material Number: 11544373049 (100 tests)All Lots lower than 29896103ARTG Numbers: 224003 (Roche Diagnostics Australia - Clinical chemistry biological screening IVDs) 212706 (Roche Diagnostics Australia - Instrument/analyser IVDs)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited